QUENCH AND PROTECT HYDRATING SPF30- zinc dioxide and titanium dioxide cream

Quench and Protect Hydrating SPF30 by

Drug Labeling and Warnings

Quench and Protect Hydrating SPF30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs., Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:
Zinc Oxide - 6.0%
Titanium Dioxide 4.7%

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, 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUENCH AND PROTECT HYDRATING SPF30 
zinc dioxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4230-2	1 in 1 CARTON	08/23/2023
1	NDC: 62742-4230-1	57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	08/23/2023

Labeler - Allure Labs. (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4230)