Label: YOUTH PROTECTION SPF 30- zinc oxide and titanium dioxide cream
- NDC Code(s): 62742-4068-1, 62742-4068-2, 62742-4068-3, 62742-4068-4
- Packager: Allure Labs, Inc
- 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 December 9, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, Glycerin, Butyrospermum Parkii Nut Extract, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Jojoba Esters , Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, PEG-100, Tetrahexyldecyl Ascorbate, Cyclohexasiloxane, Galactoarabinan, Cetyl Alcohol, Bis(Cyano Butylacetate) Anthracenediylidene, Glyceryl Acrylate/Acrylic Acid Copolymer , Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Adipic Acid/Neopentyl Glycol Crosspolymer, VP/VA Copolymer, Hydroxypropyl Methylcellulose, Amodimethicone, Steareth-20, Caprylic/Capric Triglyceride, Teprenone, Acetyl Hexapeptide-30, Arginine, Sodium Hyaluronate , Hydrolyzed Glycosaminoglycans , Propylene Glycol, Polygonum Aviculare Extract, Cetearyl Olivate, Sorbitan Olivate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Xanthan Gum, Camellia Sinensis Leaf Extract, Acetyl Hexapeptide-8, Gardenia Jasminoides Meristem Cell Culture, Sclerotium Gum, C12-15 Alkyl Benzoate, Tribehenin, Ceramide NG, PEG-10 Phytosterol, Palmitoyl Hexapeptide-12, Tocopheryl Acetate, Tocopherol, Lecithin , Arabidopsis Thaliana Extract , Micrococcus Lysate, Plankton Extract , Glucosamine HCl , Laminaria Digitata Extract, Saccharomyces Cerevisiae Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Urea, PPG-12/SMDI Copolymer, Leontopodium Alpinum Meristem Cell Culture, Crithmum Maritimum Extract, Ergothioneine, Aluminum Hydroxide, Stearic Acid, Chlorphenesin, Sodium Benzoate, Potassium Sorbate
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INGREDIENTS AND APPEARANCE
YOUTH PROTECTION SPF 30
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4068 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 186 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) SHEANUT OIL (UNII: O88E196QRF) JOJOBA BUTTER (UNII: XIA46H803R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921) CYCLOMETHICONE 6 (UNII: XHK3U310BA) GALACTOARABINAN (UNII: SL4SX1O487) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ADIPIC ACID (UNII: 76A0JE0FKJ) COPOVIDONE K25-31 (UNII: D9C330MD8B) HYPROMELLOSES (UNII: 3NXW29V3WO) STEARETH-20 (UNII: L0Q8IK9E08) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TEPRENONE (UNII: S8S8451A4O) HYALURONATE SODIUM (UNII: YSE9PPT4TH) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) XANTHAN GUM (UNII: TTV12P4NEE) CETYL ALCOHOL (UNII: 936JST6JCN) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) BETASIZOFIRAN (UNII: 2X51AD1X3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRIBEHENIN (UNII: 8OC9U7TQZ0) CERAMIDE 2 (UNII: C04977SRJ5) PEG-10 RAPESEED STEROL (UNII: 258O76T85M) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) YEAST (UNII: 3NY3SM6B8U) UREA (UNII: 8W8T17847W) PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) ERGOTHIONEINE (UNII: BDZ3DQM98W) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYL CYANOACETATE (UNII: F9H6L20VOH) LAMINARIA DIGITATA (UNII: 15E7C67EE8) ARGININE (UNII: 94ZLA3W45F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV) TOCOPHEROL (UNII: R0ZB2556P8) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) LEONTOPODIUM ALPINUM (UNII: 7R4LQP52DM) CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) AMODIMETHICONE (240 CST) (UNII: VA5T401RWV) GARDENIA JASMINOIDES WHOLE (UNII: 0PK353KHF0) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4068-2 1 in 1 CARTON 10/15/2019 1 NDC:62742-4068-1 56.7 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:62742-4068-3 28.3 g in 1 TUBE; Type 0: Not a Combination Product 10/15/2019 3 NDC:62742-4068-4 113 g in 1 TUBE; Type 0: Not a Combination Product 10/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/15/2015 Labeler - Allure Labs, Inc (926831603) Registrant - Allure Labs, Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs, Inc 926831603 manufacture(62742-4068)
