Label: 2000DL-CL30- promo spf30 lotion

  • NDC Code(s): 58418-002-00, 58418-002-01, 58418-002-02, 58418-002-04, view more
    58418-002-06, 58418-002-08, 58418-002-10, 58418-002-12, 58418-002-15, 58418-002-16, 58418-002-18, 58418-002-25, 58418-002-28, 58418-002-32, 58418-002-55, 58418-002-64, 58418-002-70, 58418-002-80
  • Packager: Tropical Enterprises International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 15, 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

    *Protect product from excessive heat and direct sun

  • QUESTIONS

    Questions: 1-877-773-9800

  • PRINCIPAL DISPLAY PANEL

    30ml

  • INGREDIENTS AND APPEARANCE
    2000DL-CL30 
    promo spf30 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-002
    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
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SORBETH-12 HEXAOLEATE (UNII: F3ECF77W74)  
    BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-002-1010 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2018
    2NDC:58418-002-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    3NDC:58418-002-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    4NDC:58418-002-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    5NDC:58418-002-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    6NDC:58418-002-80240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
    7NDC:58418-002-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
    8NDC:58418-002-16480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
    9NDC:58418-002-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
    10NDC:58418-002-283840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
    11NDC:58418-002-001.5 mL in 1 PACKET; Type 0: Not a Combination Product02/02/2020
    12NDC:58418-002-70211200 mL in 1 DRUM; Type 0: Not a Combination Product02/02/2020
    13NDC:58418-002-3240960 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product02/02/2020
    14NDC:58418-002-1545 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/02/2020
    15NDC:58418-002-1852 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/02/2020
    16NDC:58418-002-5530 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/02/2020
    17NDC:58418-002-25960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product04/24/2020
    18NDC:58418-002-06177 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2018
    Labeler - Tropical Enterprises International, Inc. (091986179)
    Registrant - Tropical Enterprises International, Inc. (091986179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Enterprises International, Inc.035229882manufacture(58418-002)
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