GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30 SUNSCREEN- homosalate, octinoxate, octocrylene, and zinc oxide cream 
Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America 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.

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GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30
SUNSCREEN CREAM

Drug Facts

Active ingredientsPurpose

Homosalate 12%

Sunscreen

Octinoxate 7.5%

Sunscreen

Octocrylene 2%

Sunscreen

Zinc Oxide 4.9%

Sunscreen

Uses

•
helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

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
•
reapply at least every 2 hours
•
use a water resistant sunscreen if swimming or sweating
•
children under 6 months of age: Ask a doctor

Inactive ingredients

aluminum starch octenylsuccinate, behentrimonium methosulfate, boron nitride, carbomer, ceramide AP, ceramide EOP, ceramide NP, cetearyl alcohol, cholesterol, dimethicone, disodium EDTA, ethoxydiglycol, glycerin, hydroxyethylcellulose, kinetin, methylparaben, niacinamide, PEG-12 glyceryl dimyristate, phytosphingosine, propylparaben, sodium hyaluronate, sodium lauroyl lactylate, water, xanthan gum, zeatin

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 OMP, Inc., Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

OBAGI®
MEDICAL

Gentle Rejuvenation
Ultra-Light Repair
SPF 30
Sunscreen Cream

Hypoallergenic
Non-comedogenic

Net wt. 1.7 oz. (50 g)

Principal Display Panel - 50 g Tube Carton
GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30  SUNSCREEN
homosalate, octinoxate, octocrylene, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE120 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE49 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CERAMIDE 3 (UNII: 4370DF050B)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
DIMETHICONE 100 (UNII: RO266O364U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
GLYCERIN (UNII: PDC6A3C0OX)  
KINETIN (UNII: P39Y9652YJ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ZEATIN (UNII: 7I6OOJ9GR6)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-131-701 in 1 CARTON
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35210/15/2013
Labeler - Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
LABORATOIRE DR RENAUD INC.202501565MANUFACTURE(62032-131) , LABEL(62032-131) , PACK(62032-131)

Revised: 10/2013
Document Id: 13520a24-3b31-4653-9cd1-5cb1ef1c742d
Set id: 5222ba81-bb97-4f0a-a465-f61c0b1d28a4
Version: 2
Effective Time: 20131015
 
Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC.