OTC Medication Information: Obagi Skintrinsiq Clarifiying Protocol

OBAGI SKINTRINSIQ CLARIFIYING PROTOCOL- salicylic acid, titanium dioxide, and zinc oxide
Obagi Cosmeceuticals LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Obagi® Medical CLENZIderm M.D.® Pore Therapy

Drug Facts

Active ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Uses

  • or the treatment of acne
  • dries up acne pimples
  • helps prevent new acne pimples

Warnings

For external use only

When using this product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Cleanse the skin thoroughly before applying this product.
  • Shake product well before use.
  • Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

  • store away from heat and direct sunlight
  • store at controlled room temperature: 15°–25°C (59°–77°F)

Inactive ingredients

benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

Questions or comments?

1.800.636.7546 Monday–Friday 9a.m.–4p.m. Pacific Time

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

Obagi™ Sun Shield Mineral Broad Spectrum SPF 50 Sunscreen

Drug Facts

Active ingredients Purpose
Titanium dioxide 6.2% Sunscreen
Zinc oxide 15.6% Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.–2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Pentylene Glycol, Steareth-2, Glycerin, Silica, Polyhydroxystearic Acid, Steareth-21, Cetearyl Alcohol, Propanediol, Alumina, Stearic Acid, Sodium Stearoyl Glutamate, Caprylyl Glycol, Triethoxycaprylylsilane, Cetearyl Glucoslde, Xanthan Gum, Dipotassium Glycyrrhizate,Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Tropaeolum Majus Flower/Leaf/Stem Extract

Other information

  • store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • protect this product from excessive heat and direct sun

Questions or comments?

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

Distributed by Obagi Cosmeceuticals LLC
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL — Kit Carton

SKINTRINSIQ™

CLARIFYING
PROTOCOL KIT

INCLUDES:

  • 60 Tips
  • Obagi Nu-Derm® Gentle Cleanser, 2 FL. OZ.
  • Obagi Nu-Derm® Toner, 2 FL. OZ.
  • CLENZIderm M.D.® Pore Therapy, 5 FL. OZ.
  • Obagi Hydrate® Facial Moisturizer, 1.7 OZ.
  • Obagi Sun Shield™ Mineral Broad Spectrum SPF 50 Sunscreen, 3 OZ.

OBAGI®

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 148 mL Bottle Label

OBAGI®
MEDICAL

CLENZIderm M.D.®

Pore Therapy

Salicylic Acid 2%
Acne Treatment

5 FL. OZ. (148 mL)

PRINCIPAL DISPLAY PANEL -- 148 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 85 g Tube Carton

OBAGI™
MEDICAL

Sun Shield
Broad
Spectrum
SPF 50

MINERAL

Sunscreen
Lotion

PA++++
Non-comedogenic
Dermatologist Tested

Net wt. 3 oz. (85 g)

PRINCIPAL DISPLAY PANEL -- 85 g Tube Carton
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
Obagi Nu-Derm Gentle Cleanser CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
Obagi Nu-Derm Toner FACE AND NECK (EXCLUDING SHAVING PREPARATIONS)
Obagi Hydrate Facial Moisturizer MOISTURIZING
OBAGI SKINTRINSIQ CLARIFIYING PROTOCOL
salicylic acid, titanium dioxide, and zinc oxide kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-909
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-909-09 1 KIT in 1 BOX None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 60 mL
Part 2 1 BOTTLE, PLASTIC 59 mL
Part 3 1 BOTTLE, PUMP 148 mL
Part 4 1 BOTTLE, PUMP 48 g
Part 5 1 TUBE 85 g
Part 1 of 5
OBAGI NU-DERM GENTLE CLEANSER
gel
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
ALOE VERA LEAF
APRICOT KERNEL OIL
BORAGO OFFICINALIS SEED
BUTYLPARABEN
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
COCAMIDOPROPYL BETAINE
DIETHYLENE GLYCOL MONOETHYL ETHER
ETHYLPARABEN
FD&C YELLOW NO. 5
GLYCERETH-7
GLYCERIN
ISOBUTYLPARABEN
METHYLPARABEN
OLEYL LACTATE
PANTHENOL
PHENOXYETHANOL
PROPYLPARABEN
SAGE
SODIUM LAURETH-3 SULFATE
SODIUM LAUROYL OAT AMINO ACIDS
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 08/01/2021
Part 2 of 5
OBAGI NU-DERM TONER
liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
ALLANTOIN
ALOE VERA LEAF
BORAGO OFFICINALIS SEED
CALENDULA OFFICINALIS FLOWER
DMDM HYDANTOIN
FD&C BLUE NO. 1
GLYCERIN
HAMAMELIS VIRGINIANA TOP WATER
IODOPROPYNYL BUTYLCARBAMATE
POLYSORBATE 80
POTASSIUM ALUM
SAGE
SODIUM PYRROLIDONE CARBOXYLATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 59 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 08/01/2021
Part 3 of 5
OBAGI MEDICAL CLENZIDERM M.D. PORE THERAPY
salicylic acid liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL
ALCOHOL
BENZYL ALCOHOL
CHAMOMILE
DIETHYLENE GLYCOL MONOETHYL ETHER
EXT. D&C VIOLET NO. 2
GLYCERIN
MENTHOL, UNSPECIFIED FORM
MENTHYL LACTATE, (-)-
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 148 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 08/01/2021
Part 4 of 5
OBAGI HYDRATE FACIAL MOISTURIZER
lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
ALLANTOIN
AVOCADO OIL
CAESALPINIA SPINOSA RESIN
CAPRYLYL GLYCOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
CETYL ALCOHOL
CYCLOMETHICONE 5
DIMETHICONE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
ETHYLHEXYLGLYCERIN
GLYCERIN
GLYCERYL MONOSTEARATE
HEXYLENE GLYCOL
LAURETH-12
LEVOMENOL
MANGIFERA INDICA SEED BUTTER
MEDIUM-CHAIN TRIGLYCERIDES
PANTHENOL
PHENOXYETHANOL
SACCHARIDE ISOMERATE
SHEA BUTTER
SODIUM HYDROXIDE
SODIUM STEAROYL GLUTAMATE
SOY STEROL
SOYBEAN
STEARIC ACID
TETRAHYDRODIFERULOYLMETHANE
TOCOPHEROL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 48 g in 1 BOTTLE, PUMP This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 08/01/2021
Part 5 of 5
OBAGI SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide and zinc oxide lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 6.2 g in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15.6 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
CAPRYLHYDROXAMIC ACID
CAPRYLYL GLYCOL
CETEARYL GLUCOSIDE
CETOSTEARYL ALCOHOL
DICAPRYLYL CARBONATE
GLYCERIN
GLYCYRRHIZINATE DIPOTASSIUM
MEDIUM-CHAIN TRIGLYCERIDES
PENTYLENE GLYCOL
POLYHYDROXYSTEARIC ACID (2300 MW)
PROPANEDIOL
SILICON DIOXIDE
SODIUM STEAROYL GLUTAMATE
STEARETH-2
STEARETH-21
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
TRISODIUM ETHYLENEDIAMINE DISUCCINATE
TROPAEOLUM MAJUS FLOWERING TOP
WATER
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TUBE in 1 CARTON contains a TUBE
1 85 g in 1 TUBE This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 08/01/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 08/01/2021
Labeler — Obagi Cosmeceuticals LLC (790553353)
Establishment
Name Address ID/FEI Operations
G.S.COSMECEUTICAL USA, INC. 017014734 MANUFACTURE (62032-909)
Establishment
Name Address ID/FEI Operations
Denison Pharmaceuticals, LLC 001207208 MANUFACTURE (62032-909)
Establishment
Name Address ID/FEI Operations
Swiss-American CDMO, LLC 080170933 MANUFACTURE (62032-909)
Establishment
Name Address ID/FEI Operations
TENCO ASSEMBLIES, INC 075535609 PACK (62032-909)

Revised: 08/2021 Obagi Cosmeceuticals LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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