PROTECT BROAD SPECTRUM SPF 30- zinc oxide 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 Ingredient:

Zinc Oxide - 18.9%

Purpose: Sunscreen

Uses:

Warnings: For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control right away.

Directions:

Protect this product from excessive heat and direct sun.

Email; info@aoskincare.com or call (415)653-3939

Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearic Acid, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isosrearic Acid, Lecithin, Cetyl Alcohol, Lanolin, Aloe Barbadensis Leaf Juice, Phomium Tenax Seed Oil, Stearyl Alcohol, Gardenia Jasminoides Meristem Cell Culture, Niacinamide, Prunus Amygdulus Dulcis (Sweet Almond) Oil, Honey, Tocopherol, Totarol, Ferulic Acid, Disodium EDTA, Xanthan Gum, Carageenan, Punica Granatum Extract, Dihydroacetic Acid, Corn Starch Modified, Benzyl Alcohol, Astaxanthin.

Distributed by Distil Skincare LLC

Mailing address: Swapbox ATUP1-1T5DK,

880 Peru Ave #2, San Francisco 94112, USA

Image Protect BS SPF 30.jpg

PROTECT BROAD SPECTRUM SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4166
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE189 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALOE (UNII: V5VD430YW9)  
PHORMIUM TENAX SEED OIL (UNII: OZ80CEA779)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GARDENIA CORNUTA WHOLE (UNII: 0WC27VVS87)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PRUNUS AMERICANA FRUIT (UNII: 3F57WKW68K)  
HONEY (UNII: Y9H1V576FH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TOTAROL (UNII: 67NH2854WW)  
FERULIC ACID (UNII: AVM951ZWST)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)  
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED (UNII: QG4MW19XYX)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ASTAXANTHIN (UNII: 8XPW32PR7I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4166-21 in 1 CARTON02/09/2018
1NDC:62742-4166-159 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/09/2018
Labeler - Allure Labs Inc (926831603)

Revised: 2/2018
Document Id: f935c5c3-284c-4dfb-a4e1-d36f6e8ad8eb
Set id: bb3796a8-ece8-4368-bf1b-ba235cf39813
Version: 1
Effective Time: 20180209
 
Allure Labs Inc