Label: CREAM- zinc oxide cream

  • 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 August 11, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Zinc Oxide 18.8%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

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

  • Directions

    Directions

    • Apply liberally 15 minutes before sun exposure
    • Apply to sll skin exposed to the sun
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Sun ProtectionMeasures
      • 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 value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10am-2pm
      • wear a long-sleeved shirt, pants, hat, and sunglasses
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water/Eau, Dodecane, Coco-Caprylate, Tricaprylin, Brassica Napus Extract, Coconut Alkanes, Simmondsia Chinensis (Jojoba) Seed Oil, Stearalkonium Bentonite, Polyglceryl-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 Aurantifolia (Lime) Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Tremella Fuciformis Sporocarp Extract, Camellia Sinensis Leaf Extract, Linoleic Acid, Lecithin, Limnanthes Alba (Meadowfoam) Seed Oil, Crambe Abyssinica Seed Oil, Camellia 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, Mauritia Flexuosa Fruit Oil, Gardenia Taitensis Flower Extract, Moringa Oleifera Seed Oil, Caryocar Brasiliense Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (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 77891), Iron Oxides (CI 77491, CI 77492, CI 77499).

  • STORAGE AND HANDLING

    Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Primary Package(Tube)

    Tube

    Tube

  • Outer Package(Carton)

    Outer-PorcelainCarton- Outer Package

  • INGREDIENTS AND APPEARANCE
    CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78518-007
    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
    CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    LIMNANTHES ALBA WHOLE (UNII: DKY81513ER)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    WATER (UNII: 059QF0KO0R)  
    DODECANE (UNII: 11A386X1QH)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    CITRUS LIMON SEED OIL (UNII: T78Z8273XO)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)  
    ULVA LACTUCA (UNII: PHR3P25W6Y)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.111 mg  in 100 mg
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL TRIOLEATE (UNII: O05EC62663)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARYOCAR BRASILIENSE FRUIT OIL (UNII: WDI9AGC94F)  
    TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
    SOLANUM LYCOPERSICUM (UNII: 0243Q4990L)  
    DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    POLYGLYCERYL-5 POLYRICINOLEATE (UNII: FT3MR7CR64)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAMELLIA OLEIFERA SEED (UNII: 59ED29FM2J)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENTONITE (UNII: A3N5ZCN45C)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BETAINE (UNII: 3SCV180C9W)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TRICAPRYLIN (UNII: 6P92858988)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78518-007-011 in 1 CARTON09/12/2022
    135 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02009/12/2022
    Labeler - MONAT GLOBAL CORP (027036949)
    Establishment
    NameAddressID/FEIBusiness Operations
    OXYGEN DEVELOPMENT, LLC137098492manufacture(78518-007)
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