QUENCH AND PROTECT HYDRATING SPF30- zinc dioxide and titanium dioxide 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 - 6.0%
Titanium Dioxide 4.7%

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, C12-15 Alkyl Benzoate, Dimethicone, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Glycerin, Cetearyl Olivate,Hexyl Laurate, Sodium Chloride, Pichia/ Resveratrol, Ferment Extract, Sorbitane Olivate, Dimethicone/Polyglycerin -3 Crosspolymer, Polyglyceryl-4 Isostearate, Panthenol, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl HexylDimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Venyl Dimethicone, Crosspolymer, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Fragrance, Tocopheryl Acetate.

Quench and Protect Hydrating SPF 30

QUENCH AND PROTECT HYDRATING SPF30 
zinc dioxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
RESVERATROL (UNII: Q369O8926L)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PANTHENOL (UNII: WV9CM0O67Z)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
CYCLOMETHICONE 7 (UNII: KCK5L8VU47)  
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4230-21 in 1 CARTON08/23/2023
1NDC:62742-4230-157 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(62742-4230)

Revised: 8/2023
Document Id: 039e50c1-7b3e-d392-e063-6394a90a4b3c
Set id: 039e50c1-7b3d-d392-e063-6394a90a4b3c
Version: 1
Effective Time: 20230823
 
Allure Labs.