NATURAL PROTECTION FACE AND EYES 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 Ingredients:

Zinc Oxide - 18.9%

Purpose: Sunscreen

Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

For external use only.

Do not use on damaged or broken skin.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Caprilic/Capric Triglyceride, Water (Aqua), Stearic Acid, Glycerin, Polysorbate 60, Sorbitan Stearate, Cetearyl Glucoside, Cetyl Alcohol, Carrageenan, Lecithin, Xanthan Gum, Stearyl Alcohol, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Phenoxyethanol, Ethylhexylglycerin.

Protect this product from excessive heat and direct sun.

Call toll free 1-800 830-1491 in the USA.

info@atzen.com

Toll free in USA: 800.830.1491

Email: info@atzen.com

www.atzen.com

Developed in France. Made in USA.

Natural Protection Face and Eyes SPF 30

Natural Protection Face and Eyes SPF 30

NATURAL PROTECTION FACE AND EYES SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4162
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
WATER (UNII: 059QF0KO0R)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4162-21 in 1 CARTON12/18/2017
1NDC:62742-4162-150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/18/2017
Labeler - ALLURE LABS INC (926831603)

Revised: 12/2017
Document Id: 94dd8ef7-cdc0-4725-82db-4853254d0643
Set id: 8f2a7b55-98f3-4bf0-873b-756cb4cc8126
Version: 1
Effective Time: 20171218
 
ALLURE LABS INC