Label: OIL CONTROLLING 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 April 27, 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 PALMITATE, ISOPROPYL ISOSTEARATE, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE, DI-PPG-3 MYRISTYL ETHER ADIPATE, SILICA, STEARIC ACID, ZINC OXIDE/CI 77947, POLYSORBATE 20, LECITHIN, POLYSILICONE-11, LAURETH-12, CYCLOPENTASILOXANE, ACRYLATES/DIMETHICONE COPOLYMER, DMDM HYDANTOIN, TRIHYDROXYSTEARIN, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, PANTHENOL, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, VIGNA RADIATA (MUNG BEAN) EXTRACT, TOCOPHERYL ACETATE, HAMAMELIS VIRGINIA (WITCH HAZEL) EXTRACT, SYMPHYTUM OFFICINALIS LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, CUCUMIS SATIVAS (CUCUMBER) FRUIT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, ALTHAEA OFFICINALIS ROOT EXTRACT, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, FRAGRANCE/PARFUM, TRISODIUM EDTA, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499, TITANIUM DIOXIDE/CI 77891]  [FRAGRANCE/PARFUM CONTAINS: LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL (LILIAL), CITRONELLOL]

  • DESCRIPTION

    AN OIL FREE, LIQUID MAKEUP THAT CONTROLS EXCESS OIL AND PROVIDES FLAWLESS COVERAGE WITHOUT SHINE.

  • 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.

  • OTHER SAFETY INFORMATION

    CLINICALLY, ALLERGY AND IRRITANCY TESTED.

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    OIL CONTROLLING MAKEUP SPF 15

    30 ML / 1 FL OZ

    Oil Control Make-Up Labeling (04-2012)

  • INGREDIENTS AND APPEARANCE
    OIL CONTROLLING MAKEUP  SPF 15
    octinoxate octisalate oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-046
    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 PALMITATE (UNII: 8CRQ2TH63M)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    LAURETH-12 (UNII: OAH19558U1)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)  
    WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)  
    MUNG BEAN (UNII: 1LIB31N73G)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-046-671 in 1 BOX
    1NDC:68828-046-1130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/19/2012
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
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