Label: SUN CARE FOR FACE- octinoxate avobenzone zinc oxide octocrylene cream

  • 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 FACE

    SPF 50

    HIGH PROTECTION

    UVA - UVB - WATER RESISTANT


    Exclusive emulsion with a a new protection system against UVA and UVB rays and active ingredients responsible for cell longevity (marine DNA, collagen, sirtuin activators).

    60ml. 2Fl.Oz.



  • Warning

    TOPICAL USE

  • Instructions for use

    Apply half hour before exposure to the sun and repeat as often as necessary.
  • PRINCIPAL DISPLAY PANEL

    FACESUNCARE
  • INGREDIENTS AND APPEARANCE
    SUN CARE  FOR FACE
    octinoxate avobenzone zinc oxide octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.5 mL  in 60 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.8 mL  in 60 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.4 mL  in 60 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.5 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM DESOXYCHOLATE (UNII: 436LS6U35Y)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LAURETH-7 (UNII: Z95S6G8201)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-120-0160 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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