Label: SUN CARE FOR BODY- octinoxate avobenzone zinc oxide octocrylene emulsion

  • 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 January 21, 2012

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  • Active Ingredient

    Octinoxate 7.5%

    Octocrylene 10%

    Avobenzone 3%

    Zinc Oxide 24%

  • Description

    SUN CARE CREAM FOR BODY

    SPF 25

    MEDIUM PROTECTION

    UVA - UVB - WATER RESISTANT


    Body emulsion rich in anti-age ingredients.  Its formula protects skin from UVB and UVA rays while moisturizing and reaffirming the skin (collagen, aloe vera, green tea).  Easy o apply for even, translucent coverage. Water resistant.

    150ml. 5Fl.Oz.



  • Warning

    TOPICAL USE

  • Instructions for use

    Dry excess sweat and apply as often as necessary.
  • PRINCIPAL DISPLAY PANEL

    FACESUNCARE
  • INGREDIENTS AND APPEARANCE
    SUN CARE  FOR BODY
    octinoxate avobenzone zinc oxide octocrylene emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE11.25 mL  in 150 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 4.5 mL  in 150 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE36 mL  in 150 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mL  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900 KD) (UNII: B70CUU14M9)  
    WATER (UNII: 059QF0KO0R)  
    TRICAPRYLIN (UNII: 6P92858988)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    C12-14 ISOPARAFFIN (UNII: WP37Z9V66A)  
    1-ETHYL-2-PYRROLECARBOXALDEHYDE (UNII: 51J1CE738Y)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    LAURETH-7 (UNII: Z95S6G8201)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-122-01150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/15/2011
    Labeler - Zenith Medicosm SL (464239694)
    Registrant - Zenith Medicosm SL (464239694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zenith Medicosm SL464239694manufacture
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