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

  • NDC Code(s): 70367-006-01, 70367-006-04
  • Packager: Only Yourx, Inc.
  • 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 September 19, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients: Octinoxate (Octyl Methoxycinnamate), Oxybenzone

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  • 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

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  • 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

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  • 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

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  • PURPOSE

    Broad spectrum UVA and UVB protection

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM MOISTURIZING SUNSCREEN-SPF 15, OCTINOXATE, OXYBENZONE 
    octinoxate, oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70367-006
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.3 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.7 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70367-006-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014
    2 NDC:70367-006-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 08/26/2014
    Labeler - Only Yourx, Inc. (089207519)
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