SUN ARMOR SPF 50- zinc oxide and titanium dioxide cream 
Allure Labs, Inc

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 8.6% and Titanium Dioxide 6.5%

Purpose: Sunscreen

Uses: To help protect the skin from harmful UVA and UVB rays. If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early aging as well as helps prevent sunburn.

Warnings: For external use only.

When using this product: Keep out of eyes. If contacts occurs, rinse with water. Discontinue use if irritation or redness occurs.

Stop use and ask a doctor: If severe skin irritation develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions: Apply sunscreen in the AM to fingertips and gently massage into the skin. Reapply as needed.

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.

Mnaufacture for Dermaquest Inc

Hayward, CA 94544

1272 GK, NL Made In USA 

ImageSunArmorSPF50

ImageSunArmorSPF50

SUN ARMOR SPF 50 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4096
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE86 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4096-21 in 1 CARTON12/01/2017
1NDC:62742-4096-156.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/29/2017
Labeler - Allure Labs, Inc (926831603)

Revised: 11/2017
Document Id: e1333fc1-1b2f-443f-9169-262ff17ab932
Set id: 6f108b71-b051-4163-8b17-c2481f60e3de
Version: 1
Effective Time: 20171129
 
Allure Labs, Inc