BIO ACTIVE COMPLEX SPF 15- 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:

Water, Caprilic/Capric Triglyceride, Polyglyceryl-2 Sesquiisostearate, Cetyl Octanoate, Cera Alba Beeswax, Sodium Hyaluronate, Caprylyl Glycol, Hexylene Glycol, Yeast Extract, Biosaccharide Gum-1, Camellia Sinensis Leaf Extract, Butyrospermum Parkii (Shea butter/Vit. A,E,F), Malus Domestica Fruit Cell Culture, Xanthan Gum, Glycerin, Lecithin, Xanthan Gum, Magnesium Sulfate, Tocopheryl Acetate, Allantoin, Magnesium Stearate, Aluminum Stearate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Phenoxyethanol, Ethylhexylglycerin, Copemicia Cerifera Wax, Oenothera Biennis Oil, Resorcinol.

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.

Bio Active Complex SPF 15

Bio Active Complex SPF 15

BIO ACTIVE COMPLEX SPF 15 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4163
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
POLYGLYCERYL-2 SESQUIISOSTEARATE (UNII: LA272Q68GQ)  
CETYL OCTACOSANOATE (UNII: O7F4812VDX)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
YEAST MANNAN (UNII: 91R887N59P)  
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)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
SHEA BUTTER (UNII: K49155WL9Y)  
MALUS DOMESTICA FLOWER (UNII: EF626V855K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
ALLANTOIN (UNII: 344S277G0Z)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
COPERNICIA ALBA WHOLE (UNII: 2HXP20S5QU)  
OENOTHERA BIENNIS (UNII: 76UI55V071)  
RESORCINOL (UNII: YUL4LO94HK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4163-21 in 1 CARTON12/18/2017
1NDC:62742-4163-130 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: 4c70ad4f-b396-4a94-920a-a75dcf67de8e
Set id: 768db334-2a0a-476d-8239-a517156c663b
Version: 1
Effective Time: 20171218
 
ALLURE LABS INC