Label: CREAM- octinoxate, zinc oxide cream

  • NDC Code(s): 61354-070-02, 61354-070-06
  • Packager: Oxygen Development LLC
  • 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 10, 2023

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  • active ingredients

    Octinoxate 5%, Zinc Oxide 5%. Purpose: Sunscreen

  • purpose

    sunscreen

  • uses

    • helps prevent sunburn
    • If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by sun
  • warnings

    for external use only

  • do not use

    on damage or broken skin

  • when using this product

    keep out of eyes. rinse with water to remove

  • stop use

    and ask a doctor if rash occurs

  • keep out of reach of children

    If swallowed, get medical help or contact a poison control center right away

  • Directions

    • Apply liberally 15 mins before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: ask a doctor
  • sun protection measures

    spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of at least 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10am - 2pm
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • inactive ingredients

    water (aqua/eau), Acetamidoethoxyethanol, Tridecyl Trimellitate, Octyldodecyl Neopentanoate, polysilicone-31, niacinimide, Cyclopentasiloxane, Cetyl Alcohol, C12-15 Alkyl Benzoate, Butylene Glycol, Aluminum Starch Octenylsuccinate, Caprylyl Methicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Isohexadecane, mica, Potassium Cetyl Phosphate, Peg-8 Dimethicone, PEG-100 Stearate, Glyceryl Stearate, glycerin, yeast extract, xanthan gum, Polyhydroxystearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxycaprylylsilane, polysorbate 80, soy amino acids, Ethylhexylglycerin, Tetrahexyldecyl Ascorbate, Arnica Montana Flower Extract.

  • other information

    protect this product from excessive heat and direct sun

  • package label - primary

    61354-070-02_AW primary

  • package label - secondary

    61354-070-06_AW secondary

  • INGREDIENTS AND APPEARANCE
    CREAM 
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 mg  in 100 mg
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-070-061 in 1 CARTON02/22/202102/10/2023
    1NDC:61354-070-0240 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/22/2021
    Labeler - Oxygen Development LLC (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development LLC137098492manufacture(61354-070)
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