Label: SEAWEED BATH CO. SHEER MINERAL SENSITIVE SPF-50- zinc oxide solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 17.0%

    Purpose

    Sunscreen

  • Uses

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

  • Warnings

    Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C). For external use only. Flammable:

    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 Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months: ask a doctor. • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every two hours.

    • 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. Sun Protection Measures:

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Algae Extract, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, a-Bisabalol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, l-Carnosine, Cetearyl Alcohol, Cetearyl Glucoside, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Fucus Vesiculosus (Seaweed) Extract, Glycerin, Glyceryl Laurate, Glyceryl Oleate, Glyceryl Stearate, Glyceryl Undecylenate, Methyl Abietate, Polyhydroxystearic Acid, Polysorbate-20, SD Alcohol, Silica, Sorbitan Stearate, Squalane, Tocopherol (Vitamin E), Ulva Lactuca (Sea Lettuce) Extract, Water, Xanthan Gum.

  • Questions?

    Call toll free 1-877-317-3106

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    SEAWEED BATH CO. SHEER MINERAL SENSITIVE SPF-50 
    zinc oxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81159-394
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION170 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CHAMOMILE (UNII: FGL3685T2X)  
    WATERMELON (UNII: 231473QB6R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYL ABIETATE (UNII: BY54I7IT3L)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SQUALANE (UNII: GW89575KF9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ULVA LACTUCA (UNII: PHR3P25W6Y)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81159-394-00177 mL in 1 CAN; Type 0: Not a Combination Product03/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/06/2023
    Labeler - The Seaweed Bath Co. (030712147)