Label: DEWY SKIN FACE- zinc oxide 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 February 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 20.8%

  • 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 on damaged 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 and evenly as the last step in your skin care routine and 15 minutes before sun exposure. Wear alone or under makeup
    • Reapply at least every two 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 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 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses.
  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Aqua/Water/Eau with Fucus Vesiculosus (Bladderwrack Seaweed) and Chlorella Vulgaris (Algae) Extracts, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-6 Distearate, Glycerin, Betaine, Glyceryl Stearate, Sorbitan Sesquioleate, Caprylhydroxamic Acid, Glyceryl Caprylate, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Natural Fragrance, Polyhydroxystearic Acid, Squalane, Niacinamide, Sodium Hyaluronate, Red Algae (Gigartina Skottsbergii) Extract, Sodium PCA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Tetrahexyldecyl Ascorbate (Vitamin C), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Sambucus Nigra (Black Elderberry) Fruit Extract, Citric Acid, Juniperus Communis Fruit Extract, Allantoin, Frangula Alnus Bark (Buckthorn) Extract, Bisabolol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Sodium Stearoyl Glutamate, Betula Alba (Birch) Leaf Extract, Tocopheryl (Vitamin E).

  • Questions?

    Call toll free 1-877-317-3106

  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Carton

    SEAWEED®
    BATH CO.

    mineral
    SPF

    hydrate & protect

    DEWY
    SKIN
    FACE
    LOTION

    with squalane
    & hyaluronic acid

    SPF 30
    SUNSCREEN

    SEA MAGIC

    Broad Spectrum SPF 30

    2.0 fl oz (59 mL)

    PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    DEWY SKIN FACE 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81159-387
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide20.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BETAINE (UNII: 3SCV180C9W)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    SQUALANE (UNII: GW89575KF9)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    ALLANTOIN (UNII: 344S277G0Z)  
    FRANGULA ALNUS BARK (UNII: S2D77IH61R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BASIL (UNII: 2U0KZP0FDW)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81159-387-001 in 1 CARTON04/01/2023
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2023
    Labeler - The Seaweed Bath Co. (030712147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc.189788201MANUFACTURE(81159-387)
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