SUN ARMOR SPF 50- zinc oxide and titanium dioxide cream

Sun Armor SPF 50 by

Drug Labeling and Warnings

Sun Armor SPF 50 by is a Otc medication manufactured, distributed, or labeled by Allure Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Zinc Oxide 8.6% and Titanium Dioxide 6.5%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

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

Warnings: For external use only.

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

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.

PRINCIPAL DISPLAY PANEL

Mnaufacture for Dermaquest Inc

Hayward, CA 94544

1272 GK, NL Made In USA 

INGREDIENTS AND APPEARANCE

SUN ARMOR SPF 50 
zinc oxide and titanium dioxide cream

Product 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)