Label: SUN ARMOR SPF 50- zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4096-1, 62742-4096-2 - 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 November 29, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients: Water (Aqua), Cyclopenatasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Alminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Glycerin, Sodium Chloride, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Cetearyl Olivate, Sorbitan Olivate, Cyclohexasiloxane, Tocopheryl Acetate, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Sodium Chondroitin Sulfate, PEG/PPG-18/18 Dimethicone, Dimethicone/Polyglycerin-3 Crosspolymer, Dimethicone / Vinyl Dimethicone Crosspolymer Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Sodium Hyaluronate, Ectoin, Cyclotetrapeptide-24 Aminocyclohexane Carboxylate, Palmitoyl Oligopepetide, Palmitoyl Tetrapeptide-7, Vitis Vinifera (Grape) Fruit Cell Extract,Polygonum Aviculare Extract, Isomalt, Sodium Benzoate, Alcohol, Lecithin, Carbomer, Polysorbate 20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Tocopherol, Ascorbic Acid, Ascorbyl Palmitate, Citric Acid.
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INGREDIENTS AND APPEARANCE
SUN ARMOR SPF 50
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4096 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 86 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 65 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) HEXYL LAURATE (UNII: 4CG9F9W01Q) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ETHYLHEXYL PALMITATE (UNII: 2865993309) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ECTOINE (UNII: 7GXZ3858RY) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) WINE GRAPE (UNII: 3GOV20705G) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) ISOMALT (UNII: S870P55O2W) SODIUM BENZOATE (UNII: OJ245FE5EU) ALCOHOL (UNII: 3K9958V90M) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) POLYSORBATE 20 (UNII: 7T1F30V5YH) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TOCOPHEROL (UNII: R0ZB2556P8) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4096-2 1 in 1 CARTON 12/01/2017 1 NDC:62742-4096-1 56.7 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 part352 11/29/2017 Labeler - Allure Labs, Inc (926831603)