Label: SPF 15 ANTI-SHINE MOISTURIZING- octinoxate and octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 29, 2011

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  • 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.

  • PRINCIPAL DISPLAY PANEL

    image of tube 50 ml label


    image of tube 50ml label

    image of carton 50ml label

    image of carton 50ml label

  • INGREDIENTS AND APPEARANCE
    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
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