Label: CREAM- zinc oxide cream

  • NDC Code(s): 61354-112-01
  • 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 July 6, 2023

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  • Active ingredient

    Zinc Oxide 18.8%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    For external use only

  • Do not use

    Do not use on damaged or broken skin

  • When using this product

    Keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor

    Stop use and ask a doctor if rash occurs

  • Keep out of reach of children

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

  • Directions

    Apply liberally 15 minutes before sun exposure.

    Apply to all skin exposed to the sun.

    Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating.

    Sun protection measures.

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a board-spectrum SPF value of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10 a.m. - 2 p.m.

    wear a long-sleeved shirt, pants, hat, and sunglasses

  • Inactive Ingredient

    Water, Dodecane, Coco-Caprylate, Tricaprylin, Brassica Napus Extract, Coconut Alkanes, Simmondsia Chinensis (Jojoba) Seed Oil, Stearalkonium Bentonite, Polyglyceryl-3 Polyricinoleate, Oryza Sativa (Rice) Bran Extract, Propanediol, Caprylic/Capric Triglyceride, Glyceryl Caprylate, Coco-Caprylate/Caprate, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone, Cocos Nucifera (Coconut) Oil, Citrus Limon (Lemon) Peel Oil, Citrus Aurantofolia (Lime) Oil, Citrus Aurantium Bergamia (Bergamot)Fruit Oil, Tremella Fucformis Sporocarp Extract, Camelia Sinensis Leaf Extract, Linoleic Acid, Lecithin, Limnanther Alba (Meadowfoam (Speed Oil, Crambe Abyssinica Seed Oil, Camelia Oleifera Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil, Phytosteryl Canola Glycerides, Oleic Acid, Palmitic Acid, Stearic Acid, Triolein, Tocopherol, Adansonia Digitata Oil, Maurita Flexuosa Fruit Oil, Gardenia Taitensis Flowe Extract, Moringa Oleifera Seed Oil, Caryocar Brasiliense Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Olea Europea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Extract, Triheptanoin, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Tocopherol Acetate, Ulva Lactuca Extract, Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Triethyl Citrate, Glycerin, Betain, Glyceryl Undecylenate, Potassium Sorbate, Sodium Benzoate, Bentonite, May Contain: Titanium Dioxide (CI 77492), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • Other Information

    Protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    61354-112-aw61354-112-01_aw61354-112_aw

  • INGREDIENTS AND APPEARANCE
    CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.8 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    TRICAPRYLIN (UNII: 6P92858988) 7 mg  in 100 mg
    JOJOBA OIL (UNII: 724GKU717M) 2.76 mg  in 100 mg
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) 2.04 mg  in 100 mg
    RICE BRAN (UNII: R60QEP13IC) 2 mg  in 100 mg
    COCO-CAPRYLATE (UNII: 4828G836N6) 1.99 mg  in 100 mg
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) 1.04 mg  in 100 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) 1 mg  in 100 mg
    TRIHEPTANOIN (UNII: 2P6O7CFW5K) 0.91 mg  in 100 mg
    WATER (UNII: 059QF0KO0R) 28.37 mg  in 100 mg
    STEARALKONIUM ION (UNII: UMO7T7E1XN) 2.6 mg  in 100 mg
    BENTONITE (UNII: A3N5ZCN45C) 0.93 mg  in 100 mg
    DODECANE (UNII: 11A386X1QH) 11.96 mg  in 100 mg
    BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4) 3.5 mg  in 100 mg
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 1.33 mg  in 100 mg
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 1 mg  in 100 mg
    PROPANEDIOL (UNII: 5965N8W85T) 2 mg  in 100 mg
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) 1.2 mg  in 100 mg
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 1.5 mg  in 100 mg
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) 1.32 mg  in 100 mg
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 0.52 mg  in 100 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 1.57 mg  in 100 mg
    FERRIC OXIDE RED (UNII: 1K09F3G675) 1.51 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-112-011 in 1 CARTON07/06/2023
    1100 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02007/06/2023
    Labeler - Oxygen Development LLC (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development LLC137098492manufacture(61354-112)
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