Label: SEAWEED BATH CO. SPF-30- octocrylene, zinc oxide, octisalate cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 11, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredient

    Octocrylene 5.0% 

    Octisalate 5.0%

    Zinc Oxide 5.0%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating.

  • 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 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 • A t 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 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-sleeve shirts, pants, hats and sunglasses. Sun Protection Measures:

  • Inactive Ingredients:

    Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter), Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dehydroacetic Acid, Fucus Vesiculosus (Bladderwrack Seaweed) Extract, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Natural Fragrance, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Simmondsia Chinensis (Jojoba) Oil, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Water, Xanthan Gum.

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • Questions?

    Call toll free 1-877-317-3106

  • Package Labeling:

    Bottle3

  • INGREDIENTS AND APPEARANCE
    SEAWEED BATH CO. SPF-30 
    octocrylene, zinc oxide, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81159-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATERMELON (UNII: 231473QB6R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOA (UNII: D9108TZ9KG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81159-133-00100 mL in 1 TUBE; Type 0: Not a Combination Product11/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/23/2020
    Labeler - The Seaweed Bath Co. (030712147)