Label: QUENCH AND PROTECT HYDRATING SPF30- zinc dioxide and titanium dioxide cream
- NDC Code(s): 62742-4230-1, 62742-4230-2
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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 creamProduct 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)