Label: TROPICAL TOPICAL MATTE SPF30- zinc oxide cream

  • NDC Code(s): 62742-4231-1, 62742-4231-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 23, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    Zinc Oxide – 18.6 %

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn. If used as directed with other sun protection measures, this product decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    Warning:

    For external use only

  • DO NOT USE

    Do not use on damage or broken skin.

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children if product is swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Direction:

    Apply liberally 15 minutes before sun exposure.

    Children under 6 month of age: Ask a doctor

    Reapply at least every 2 hours.

    Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun< especially from 10 am – 2.0 pm, Wear long – sleeved shirts, pants, hats and sunglasses.

  • OTHER SAFETY INFORMATION

    Other Information:

    Protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT: Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Sorbitan Stearate, Cetyl Alcohol, Teprenone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylic/Capric Triglyceride, Imperata Cylendrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Lecithin, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/ Oleate, Citric Acid, Polyacrylamide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Xanthan Gum, C13-14 Isoparaffin, Laureth-7, PEG-8, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Asccorbyl Palmitate, Ascorbc Acid, Fragrance, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    Tropicaltopicalmatte SPF30

  • INGREDIENTS AND APPEARANCE
    TROPICAL TOPICAL MATTE SPF30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    DATE (UNII: H3O7QI5HY7)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    TEPRENONE (UNII: S8S8451A4O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4231-21 in 1 CARTON08/23/2023
    1NDC:62742-4231-157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/23/2023
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4231)