OTC Medication Information: Obagi Skintrinsiq Antioxidant Protocol

OBAGI SKINTRINSIQ ANTIOXIDANT PROTOCOL- avobenzone, homosalate, octisalate. octocrylene, and oxybenzone
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® Professional-C™ Suncare SPF 30

Drug Facts

Active ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 8% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 2.79% Sunscreen
Oxybenzone 3% 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. If product gets into eyes, rinse with water to remove.

Stop use and ask a 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
  • 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
  • children under 6 months: Ask a doctor

Other information

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

Inactive ingredients

ascorbic acid, citrus grandis (grapefruit) peel extract, dimethicone, dimethicone crosspolymer, fragrance, octoxynol-9

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™

ANTIOXIDANT 10%
PROTOCOL KIT

INCLUDES:

  • 60 Tips
  • Obagi Nu-Derm® Gentle Cleanser, 2 FL. OZ.
  • Obagi Nu-Derm® Toner, 2 FL. OZ.
  • Obagi Professional-C® Serum 10%, 1 FL. OZ.
  • Obagi Professional-C® Peptide Complex, 1 FL. OZ.
  • Obagi Professional-C® Suncare SPF 30, 1.7 OZ.

OBAGI®

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

PRINCIPAL DISPLAY PANEL — 48 g Tube Carton

OBAGI®
MEDICAL

Professional-C™
SUNCARE

BROAD SPECTRUM
SPF 30

SUNSCREEN

Net wt. 1.7 oz. (48 g)

PRINCIPAL DISPLAY PANEL -- 48 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 Professional-C Serum FACE AND NECK (EXCLUDING SHAVING PREPARATIONS)
Obagi Professional-C Peptide Complex MOISTURIZING
OBAGI SKINTRINSIQ ANTIOXIDANT PROTOCOL
avobenzone, homosalate, octisalate. octocrylene, and oxybenzone kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-906
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-906-06 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, DROPPER 30 mL
Part 4 1 BOTTLE, PUMP 30 mL
Part 5 1 BOTTLE, PUMP 48 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 PROFESSIONAL-C SERUM
liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
ASCORBIC ACID
PROPYLENE CARBONATE
PROPYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER 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 4 of 5
OBAGI PROFESSIONAL-C PEPTIDE COMPLEX
lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
.ALPHA.-TOCOPHEROL ACETATE
ACETYL OCTAPEPTIDE-3
ALMOND OIL
CAPRYLYL GLYCOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
CETYL ALCOHOL
DIETHYLENE GLYCOL MONOETHYL ETHER
EDETATE DISODIUM ANHYDROUS
ETHYLHEXYLGLYCERIN
GLYCERYL MONOSTEARATE
GREEN TEA LEAF
HYALURONATE SODIUM
HYDROCHLORIC ACID
IMIDUREA
KINETIN
MEDIUM-CHAIN TRIGLYCERIDES
ORANGE OIL
PANTHENOL
PEG-100 STEARATE
PEG-12 GLYCERYL DIMYRISTATE
PHENOXYETHANOL
POLYAMINOPROPYL BIGUANIDE
PPG-12/SMDI COPOLYMER
SILICON DIOXIDE
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85)
STEARIC ACID
TETRAHEXYLDECYL ASCORBATE
TROLAMINE
WATER
ZEATIN
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 30 mL 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 PROFESSIONAL-C SUNCARE SPF 30
avobenzone, homosalate, octisalate. octocrylene, and oxybenzone lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 8 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 2.79 g in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CITRUS MAXIMA FRUIT RIND
DIMETHICONE
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
OCTOXYNOL-9
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
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 (62032-906)
Establishment
Name Address ID/FEI Operations
Denison Pharmaceuticals, LLC 001207208 MANUFACTURE (62032-906)
Establishment
Name Address ID/FEI Operations
Swiss-American CDMO, LLC 080170933 MANUFACTURE (62032-906)
Establishment
Name Address ID/FEI Operations
TENCO ASSEMBLIES, INC 075535609 PACK (62032-906)

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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