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 — 148 mL Bottle Label

OBAGI^®
MEDICAL

CLENZIderm M.D.^®

Pore Therapy

Salicylic Acid 2%
Acne Treatment

5 FL. OZ. (148 mL)

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)

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