TROPICAL TOPICAL MATTE SPF30- zinc oxide cream 
Allure Labs

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.

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Drug Facts

ACTIVE INGREDIENTS:
Zinc Oxide – 18.6 %

Purpose: Sunscreen

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.

Warning:

For external use only

Do not use on damage or broken skin.

When using this product keep out of eye. 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.

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 Information:

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

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.

Tropicaltopicalmatte SPF30

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)

Revised: 8/2023
Document Id: 039fba4b-720b-9199-e063-6394a90adbfb
Set id: 039fba4b-720a-9199-e063-6394a90adbfb
Version: 1
Effective Time: 20230823
 
Allure Labs