Label: BROAD SPECTRUM MOISTURIZING SUNSCREEN-SPF 15, OCTINOXATE, OXYBENZONE- octinoxate, oxybenzone lotion

  • 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 January 23, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients: Octinoxate (Octyl Methoxycinnamate), Oxybenzone

  • INACTIVE INGREDIENT

    Other Ingredients: Water, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Allantoin, Aloe Vera Powder, D-Panthenol, Sodium Edetate, Squalane, Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60, Phenoxyethanol, Ethylhexylglycerin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroethylacrylate/Sodium Acryloyldimethyl Copolymer, Aminomethylpropanol

  • DOSAGE & ADMINISTRATION

    USE INSTRUCTIONS: Apply a liberal amount aproximately 30 minutes prior to sun exposure. For continuous protection, reapply regularly and after swimming and/or exercising

  • INDICATIONS & USAGE

    Broad spectrum UVA and UVB protection. Lightweight lotion suitable for even oily skin helps to protect damaging rays, moisture loss and premature aging of the skin

  • PURPOSE

    Broad spectrum UVA and UVB protection

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • WARNINGS

    Warnings: For external use only; Do not use on damaged or broken skin; Stop use and ask a doctor if rash occurs; When using this product keep out of eyes; Rinse with water to remove

  • PRINCIPAL DISPLAY PANEL

    BROAD SPECTRUM MOISTURIZING SPF 15

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM MOISTURIZING SUNSCREEN-SPF 15, OCTINOXATE, OXYBENZONE 
    octinoxate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.3 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    SQUALANE (UNII: GW89575KF9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70367-006-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    2NDC:70367-006-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/26/2014
    Labeler - Only Yourx, Inc. (089207519)