Label: SKIN DEFENSE MAKEUP SPF-15- octinoxate octisalate oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 23, 2012

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  • ACTIVE INGREDIENT

    SUNSCREEN ACTIVE INGREDIENT (SPF 15):
    OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3
  • PURPOSE

    PURPOSE: SUNSCREEN

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL ISOSTEARATE, DI-PPG-3 MYRISTYL ETHER ADIPATE, STEARIC ACID, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE,  LECITHIN, POLYETHYLENE, METHYL METHACRYLATE COPOLYMER, SILICA, DIMETHICONE, SODIUM HYALURONATE, TREHALOSE, SODIUM PCA, POLYQUATERNIUM-51, UREA, GLYCERIN, AVENA SATIVA (OAT) KERNEL EXTRACT, POLYSORBATE 20, TRIETHANOLAMINE, TAGETUS ERECTA (AFRICAN MARIGOLD) EXTRACT, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, PROPYLENE GLYCOL, MACROCYSTIS PYRIFERA EXTRACT,  HYDROLYZED WHEAT PROTEIN, PVP, DMDM HYDANTOIN, BIOSACCHARIDE GUM-4, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, FRAGRANCE/PARFUM, PANTHENOL, TOCOPHERYL ACETATE, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA [MAY CONTAIN, +/-: TITANIUM DIOXIDE/CI 77891, IRON OXIDES/CI 77491/CI 77492/CI 77499]  [FRAGRANCE/PARFUM CONTAINS: CITRONELLOL, ALPHA-ISOMETHYL IONONE, GERANIOL, LIMONENE, LINALOOL].

  • INDICATIONS & USAGE

    SPF 15 PROTECTS AGAINST DAMAGING ULTRAVIOLET RAYS. MATTE FINISH. SHEER TO MEDIUM COVERAGE.

  • INSTRUCTIONS FOR USE

    TO USE: SMOOTH ON WITH FINGERS OR SPONGE.

  • WARNINGS

    CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

  • STOP USE

    DISCONTINUE USE IF SIGNS OF IRRITATION OCCUR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    SKIN DEFENSE MAKEUP SPF 15

    Skin Defense MU SPF-15_ART_Box_30mLSkin Defense MU SPF-15_ART_LBL-FR_30mLSkin Defense MU SPF-15_ART_LBL-BK_30mLSkin Defense MU SPF-15_ART_Tester Box-FRSkin Defense MU SPF-15_ART_Tester Box-BK

  • INGREDIENTS AND APPEARANCE
    SKIN DEFENSE MAKEUP  SPF-15
    octinoxate octisalate oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-147
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)  
    UREA (UNII: 8W8T17847W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OAT (UNII: Z6J799EAJK)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TAGETES ERECTA FLOWER (UNII: UH5X33P33E)  
    IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    POVIDONE K30 (UNII: U725QWY32X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-147-111 in 1 BOX
    1NDC:68828-147-6730 mL in 1 BOTTLE
    2NDC:68828-147-1010 in 1 BOX
    2NDC:68828-147-178 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/24/2012
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture
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