SPF 15 ANTI-SHINE MOISTURIZING - octinoxate and octocrylene lotion 
Laboratoire Dr Renaud Inc.

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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Drug Facts

Active Ingredients

Octinoxate (Octyl Methoxycinnamate) 7.77% w/w and Octocrylene 0.10% w/w

INACTIVE INGREDIENTS

WATER/EAU • BIOSACCHARIDE GUM-1 • METHYL GLUCETH-20 • GLYCERIN •VITIS VINIFERA (GRAPE) SEED OIL • DICAPRYLYL CARBONATE • METHYLMETHACRYLATE CROSSPOLYMER • SACCHARIDE ISOMERATE • CETEARYL OLIVATE • DIPROPYLENE GLYCOL • SORBITAN OLIVATE • CANDIDA BOMBICOLA/GLUCOSE/METHYL RAPESEEDATE FERMENT • SILICA • ALPHA GLUCAN OLIGOSACCHARIDE • TALC • SODIUM PALMITOYL PROLINE • AMMONIUM ACRYLOYL DIMETHYLTAURATE/VP COPOLYMER • OLEA EUROPAEA (OLIVE) LEAF EXTRACT • NYMPHEA ALBA FLOWER EXTRACT • HELIANTHUS ANNUUS (SUNFLOWER) OIL • XANTHAN GUM • KAEMPFERIA GALANGA (GALANGAL) EXTRACT • ROSMARINUS OFFICINALIS (ROSEMARY) OIL • SARCOSINE • SALVIA SOLAREA (CLARY SAGE) OIL • CITRUS AURANTIUM (ORANGE) OIL • CITRUS RETICULATA BLANCO (MANDARIN) OIL • BUTYLENE GLYCOL • GLUCAMINE • CHLORPHENESIN • CITRUS LIMON (LEMON) OIL • CITRUS AURANTIFOLIA (LIME) OIL • CYMBOPOGON SCHOENANTHUS (LEMONGRASS) OIL • PHENOXYETHANOL • ETHYLHEXYLGLYCERIN • BHT • PVP •


In the morning, first cleanse the skin thoroughly. Then apply a thin layer of your specific skin care product. End with the application of the Anti-Shine Moisturizing Lotion SPF 15. Apply prior to sun exposure.

For external use only. Keep out of reach of children. Avoid direct contact with the eyes. If product gets into the eyes, rinse liberally with water. Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor.

image of tube 50 ml label


image of tube 50ml label

image of carton 50ml label

image of carton 50ml label

SPF 15 ANTI-SHINE MOISTURIZING 
octinoxate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62499-445
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.77 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
METHYL METHACRYLATE (UNII: 196OC77688)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
TALC (UNII: 7SEV7J4R1U)  
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLUCAMINE (UNII: 5QN16UUF80)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
POVIDONE K30 (UNII: U725QWY32X)  
LESSER GALANGAL ROOT (UNII: 42LD90786Y)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
SARCOSINE (UNII: Z711V88R5F)  
CLARY SAGE OIL (UNII: 87L0D4U3M0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ORANGE OIL (UNII: AKN3KSD11B)  
MANDARIN OIL (UNII: NJO720F72R)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
LEMON OIL (UNII: I9GRO824LL)  
LIME OIL (UNII: UZH29XGA8G)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
Product Characteristics
Colorblue (dark bleu) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62499-445-111 in 1 CARTON
1NDC:62499-445-0450 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/29/2011
Labeler - Laboratoire Dr Renaud Inc. (202501565)
Registrant - Laboratoire Dr Renaud Inc. (202501565)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoire Dr Renaud Inc.202501565manufacture

Revised: 11/2011
Document Id: 2362cebc-f7d7-468f-930f-a85e96afad5d
Set id: fd4d2959-a8cb-4e88-9bf9-e1350d7e609b
Version: 3
Effective Time: 20111129
 
Laboratoire Dr Renaud Inc.