Label: MOISTURIZING SUNSCREEN SPF15- oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL

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 June 2, 2011

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  • PURPOSE

    For Sun protection: Apply on surfaces of skin, on face, arm and hand. SPF-15 provides the face and body skin with effective protection against harmful UVA and UVB rays. Use daily over moisture cream to help prevent premature aging and wrinkling due to prolonged exposure to the sun, reapply after swimming or excessive exercise.

  • INDICATIONS & USAGE

    Smear Lightly.

  • WARNINGS

    Warning: For external use only, not to be swallowed. Avoid contact with eye. Discontinue if signs of irritation or rash appear.

  • DOSAGE & ADMINISTRATION

    To Apply lightly.

  • INACTIVE INGREDIENT

    Inactive Ingredients: SORBITAN SESQUIOLEATE, POLYSORBATE 60, CARBOMER 934, VITAMIN E ACETATE, STEARIC ACID, PROPYLENE GLYCOL, VITAMIN A PALMITATE, PROPYLPARABEN, Water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of the reach of children. Use on children under six months of age only with the advice of a physician.

  • ACTIVE INGREDIENT

    OXYBENZONE and OCTINOXATE.

  • PRINCIPAL DISPLAY PANEL

    MM1label

  • INGREDIENTS AND APPEARANCE
    MOISTURIZING SUNSCREEN SPF15 
    oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59663-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1 mL  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CARBOMER 934 (UNII: Z135WT9208)  
    VITAMIN E ACETATE (UNII: 9E8X80D2L0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59663-001-01100 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/02/1996
    Labeler - Shine & Pretty (USA), Corp. (603528605)
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