Label: TENDER MOMENTS SPF 45- homosalate octinoxate octisalate oxybenzone titanium dioxide octocrylene 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 16, 2012

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  • ACTIVE INGREDIENT

    SUNSCREEN ACTIVE INGREDIENT (SPF 45): TITANIUM DIOXIDE, OXYBENZONE/BENZOPHENONE-3, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
  • PURPOSE

    PURPOSE: SUNSCREEN

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: WATER/AQUA, ALUMINA, DIMETHICONE, SODIUM DIHYDROXYCETYL PHOSPHATE, GLYCERYL STEARATE SE, ADIPIC ACID/DIETHYLENE GLYCOL/GLYCERIN CROSSPOLYMER, PVP/EICOSENE COPOLYMER, AVENA SATIVA (OAT) KERNEL EXTRACT, PANTHENOL, TOCOPHERYL  ACETATE, BUTYLENE GLYCOL, CETYL ALCOHOL, XANTHAN GUM, FRAGRANCE/PARFUM, DMDM HYDANTOIN, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA, [FRAGRANCE/PARFUM CONTAINS: CITRONELLOL, GERANIOL, HEXYL CINNAMAL, HYDROXYCITRONELLOL, BUTYLPHENYL METHYLPROPIONAL (LILLIAL), LINALOL, ALPHA-ISOMMETHYL IONONE]

  • INDICATIONS & USAGE

    BABY BLOCK SPF 45

  • DOSAGE & ADMINISTRATION

    APPLY WATER-RESISTANT SUNSCREEN 20 MINUTES BEFORE SUN EXPOSURE.

  • STOP USE

    DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    TENDER MOMENTS
    BABY BLOCK SPF 45

    JAFRA

    Tender Moments SPF-45 ART_50mL_Tube-FR

    Tender Moments SPF-45 ART_50mL_Tube-BK

  • WARNINGS

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

  • PEDIATRIC USE

    SEEK THE ADVICE OF A PHYSICIAN PRIOR TO USE ON CHILDREN UNDER 6 MONTHS OF AGE.

  • INGREDIENTS AND APPEARANCE
    TENDER MOMENTS  SPF 45
    homosalate octinoxate octisalate oxybenzone titanium dioxide octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.7 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIETHYLENE GLYCOL ADIPATE (UNII: 6KE5V549E0)  
    OAT (UNII: Z6J799EAJK)  
    POVIDONE K30 (UNII: U725QWY32X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-060-1350 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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