Label: BIO ACTIVE COMPLEX SPF 15- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4163-1, 62742-4163-2 - Packager: ALLURE LABS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 18, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIO ACTIVE COMPLEX SPF 15
zinc oxide creamProduct 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)
