Label: PROTECTIVE FOUNDATION SUNSCREEN SPF 15- sunscreen, avobenzone, octinoxate emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 13, 2013

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  • PURPOSE

    USES: HELPS PREVENT SUNBURNS.

  • DOSAGE & ADMINISTRATION

    RECOMMENDATION:  PLACE A SMALL AMOUNT ON A SPONGE, BLEND EVENLY OVER FACE

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    OCTINOXATE 6%
    AVOBENZONE 2%

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: WATER (DEIONIZED), GLYCERETH-26, CAPRYLIC/CAPRIC/STEARIC TRIGLLYCERIDE, ISOPROPYL PALMITATE, KAOLIN, PROPYLENE GLYCOL, POLYSORBATE 20, GLYCERYL STEARATE, STEARIC ACID, DIMETHICONE, PRUNUS AMYGDALUS DULCIS (SWEEK ALMOND)OIL, SIMMONDSIA CHINENSIS (JOJOBA) OIL, AHNFELTIA CONCINNA EXTRACT, SODIUM HYALURONATE, TOCOPHEROL, SORBITAN STEARATE, SORBITAN PALMITATE, CETYL ALCOHOL, BIS-DIGLYCERYL POLYACYLADIPATE-2, PHENOXYETHANOL, TRIETHANOLAMINE, MAGNESIUM ALUMINUM SILICATE, LECITHIN, OLETH-20, SQUALENE (VEG ORIGIN), CORN STARCH MODIFIED, CELLULOSE GUM, CITRIC ACID, TRISODIUM EDTA, BUTYLENE, BUTYLPARABEN, MAY CONTAIN:TITANIUM DIOXIDE, IRON OXIDE.

  • WARNINGS

    WARNINGS: FOR EXTERNAL USE ONLY, IF SWALLOWED SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY, IF CONTACT WITH EYES OCCURS, RINSE THOROUGHLY WITH WATER, DISCONTINUE USE AND CONSULT A DOCTOR IF PERSISTENT SIGNS OF IRRITATION OR RASH APPEAR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    carton
    image of carton label
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    image of pump label




  • INGREDIENTS AND APPEARANCE
    PROTECTIVE FOUNDATION SUNSCREEN SPF 15 
    sunscreen, avobenzone, octinoxate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.02 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    1-BUTENE (UNII: LY001N554L)  
    AHNFELTIOPSIS CONCINNA (UNII: SMF2K46G8D)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    OLETH-20 (UNII: YTH167I2AG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SQUALENE (UNII: 7QWM220FJH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    TRICAPRYLIN (UNII: 6P92858988)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62191-007-0230 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2002
    Labeler - Sunrider Manufacturing L.P. (786951475)
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