Label: 2000DL-CL30V- spf30 bs vanilla lotion

  • NDC Code(s): 58418-003-06
  • Packager: Tropical Enterprises International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Avobenzone 3%

    Octocrylene 8%

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    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

    WARNINGS: Skin Cancer/ Sking Aging Alert: Spending time in the sun

    increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer and early skin aging.

    For external use only.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if irritation or rash occurs.

  • Keep out of reach of children.

    Keep out of reach of children. If product is swallowed, get immediate medical help or contact a Poison Control Center

    right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally 15 minutes before sun exposure
    • Reapply:

    ​*after 80minutes of swimming or sweating

    * immediately after towel drying

    *at least every 2 hours

    *Children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Acrylates/C10-30, Alkyl Acrylate cross polymer, Stearic Acid, Glyceryl Monostearate, Bis-Octyldodecyl Dimer Dillinoleate/Propanediol Copolymer, Sorbeth-2-Hexaoleate, Phenoxylethanol, Ethylhexylglycerin, Triethanolamine, Disodium EDTA.

  • OTHER SAFETY INFORMATION

    Other Information: Protect product from excessive heat and direct sun

  • QUESTIONS

    Questions or comments? Call toll free 1-800-535-5053

  • PRINCIPAL DISPLAY PANEL

    Vanilla spf30

  • INGREDIENTS AND APPEARANCE
    2000DL-CL30V 
    spf30 bs vanilla lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.34 g  in 30 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.9 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SORBETH-12 HEXAOLEATE (UNII: F3ECF77W74)  
    BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    Product Characteristics
    Colorwhite (white to off-white) Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-003-06177 mL in 1 TUBE; Type 0: Not a Combination Product10/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2023
    Labeler - Tropical Enterprises International, Inc. (091986179)
    Registrant - Tropical Enterprises International, Inc. (035229882)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Enterprises International, Inc.035229882manufacture(58418-003)
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