Label: SUN SAVVY SOLAR SHIELD SPF 20- zinc oxide titanium dioxide 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 October 6, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    ZINC OXIDE 5% TITANIUM DIOXIDE 5%
  • PURPOSE

    PURPOSE:
    SUNSCREEN
  • INDICATIONS & USAGE

    USES: PREVENTION OF SUNBURN, REDUCTION OF SKIN DAMAGE AND PREMATURE AGING CAUSED BY SUN EXPOSURE.
  • WARNINGS

    WARNING: FOR EXTERNAL USE ONLY.
  • WHEN USING

    WHEN USING THIS PRODUCT: KEEP OUT OF EYES, RINSE WITH WATER TO REMOVE.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY A SMALL AMOUNT EVENLY BEFORE SUN EXPOSURE AND AS NEEDED. ASK A DOCTOR BEFORE USE ON CHILDREN UNDER 6 MONTHS OF AGE. REAPPLY AFTER TOWEL DRYING, SWIMMING OR PERSPIRING.
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION: LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING AND USING SUNSCREEN MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER AND OTHER HARMFUL AFFECTS OF THE SUN. MAY STAIN FABRIC.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: PURIFIED WATER, CETYL DIMETHICONE COPOLYOL, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, ETHYLHEXYL PALMITATE, ISOHEXADECANE, CAPRIC CAPRYLIC TRIGLYCERIDES, DIMETHICONE, CETYL DIMETHICONE, SODIUM CHLORIDE, SODIUM PCA, PHENOXYETHANOL, ISOPENTYLDIOL, CAPRYLYL GLYCOL, ALLANTOIN.
  • PRINCIPAL DISPLAY PANEL

    DERMAGENICS
    PHYSICIAN FORMULATED

    SUN SAVVY
    SOLAR SHIELD

    FACIAL SUNSCREEN
    WITH REVERSE EMULSION
    TECHNOLOGY

    PHYSICAL BARRIER
    95% UVA/UVB
    PROTECTION

    SPF 20
    4 FL OZ
    ART dermagenics_solar_shield_BK
    ART dermagenics_solar_shield_FR
  • INGREDIENTS AND APPEARANCE
    SUN SAVVY SOLAR SHIELD  SPF 20
    zinc oxide titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55071-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55071-001-04118 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/26/2011
    Labeler - APPLIED SKIN TECHNOLOGY LLC (036766984)
    Registrant - CRC (Cosmoceutical Research Center) (160019006)
    Establishment
    NameAddressID/FEIBusiness Operations
    CRC (Cosmoceutical Research Center)160019006manufacture
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