BIO ACTIVE COMPLEX SPF 15- zinc oxide cream

Bio Active Complex SPF 15 by

Drug Labeling and Warnings

Bio Active Complex SPF 15 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 - 18.9%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

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.

WARNINGS

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

Keep out of eyes. Rinse with water to remove.

STOP USE

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 Center right away.

DOSAGE & ADMINISTRATION

Directions:

• Apply liberally 15 minutes prior to sun exposure.
• Reapply: after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in sun sun, especially from 10 am - 2 pm.
• wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT

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.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS

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

info@atzen.com

PRINCIPAL DISPLAY PANEL

Toll free in USA: 800.830.1491

Email: info@atzen.com

www.atzen.com

Developed in France. Made in USA.

INGREDIENTS AND APPEARANCE

BIO ACTIVE COMPLEX SPF 15 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4163-2	1 in 1 CARTON	12/18/2017
1	NDC: 62742-4163-1	30 mL 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	12/18/2017

Labeler - ALLURE LABS INC (926831603)