REEF BABIES SPF 50 OXYBENZONE FREE (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]

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  • REEF BABIES SPF 50 OXYBENZONE FREE (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]

REEF BABIES SPF 50 OXYBENZONE FREE (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]
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NDC 52854-515-01
Set ID 8cd68b09-2578-4519-b00e-e83e0e440815
Category HUMAN OTC DRUG LABEL
Packager Tropical Seas, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octocrylene 10.0%

    Octisalate 5.0%

    Avobenzone 3.0%

  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • 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 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
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    aqueous extracts of: aloe barbadensis leaf extract, algae extract (hawaiian seaplant), chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root & leaf extract, taraxacum officinale (dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis (marshmallow) root extract, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea) extract, phenethyl benzoate, octyl dodecyl citrate crosspolymer, stearic acid, glyceryl stearate se, cetyl dimethicone, glycerin, sodium hydroxide, emulsifying wax, tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, cetyl alcohol, methylparaben, diazolidinyl urea, propylparaben, and caprylyl glycol.

  • Other Information

    • protect this product from excessive cold, heat, and direct sun.
  • Questions or comments?

    Call toll free 1-800-368-7327

  • Principal Display Panel - 120 mL Bottle Label

    120ml NDC 52854-515-01 120ml front label120ml back label

  • INGREDIENTS AND APPEARANCE
    REEF BABIES SPF 50 OXYBENZONE FREE 
    octocrylene, octisalate, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SYMPHYTUM UPLANDICUM LEAF (UNII: D05HXK6R3G)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    AMERICAN GINSENG (UNII: 8W75VCV53Q)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52854-515-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2017
    Labeler - Tropical Seas, Inc. (627865660)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Seas, Inc.627865660manufacture(52854-515)
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