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 — 48 g Tube Carton

OBAGI^®
MEDICAL

Professional-C™
SUNCARE

BROAD SPECTRUM
SPF 30

SUNSCREEN

Net wt. 1.7 oz. (48 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 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