Label: REEF SAFE SPF 36- octinoxate, oxybenzone, octisalate, and homosalate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 7, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate 7.5%

    Oxybenzone 6.0%

    Octisalate 5.0%

    Homosalate 4.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to prevent sunburn, not skin cancer or early skin aging.

    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
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    aqueous extracts of: aloe barbadensis leaf extract, algea extract (hawaiian seaplant), chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root and 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, camellia sinensis (white tea) extract, stearic acid (vegetable derived), glyceryl stearate se (vegetable derived), titanium dioxide, cetyl dimethicone, glycerin (coconut derived), sodium hydroxide, emulsifying wax (vegetable derived), tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, methylparaben, cetyl alcohol (vegetable derived), diazolidinyl urea and propylparaben.

  • Other Information

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

    Call toll free 1-800-368-7327

  • Principal Display Panel - Bottle Label

    Biodegradeable

    Reef Safe
    BY TROPICAL SEAS
    ®

    SPF36+ Bait Safe Off Shore Sport

    Original Formula

    Water Resistant (80 minutes)

    Sunscreen Lotion

    4 fl. oz. (120ml)

    Non-Toxic to Sealife

    Principal Display Panel - Bottle Label


  • INGREDIENTS AND APPEARANCE
    REEF SAFE SPF 36 
    octinoxate, oxybenzone, octisalate, and homosalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4 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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52854-036-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1995
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/1995
    Labeler - Tropical Seas, Inc. (627865660)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Seas, Inc.627865660manufacture(52854-036)