Label: ALIVE PREBIOTIC BALANCING MOISTURIZER SPF 15- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71047-262-10, 71047-262-50 - Packager: Algenist, LLC
- Category: HUMAN OTC DRUG LABEL
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 September 14, 2018
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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Uses
Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
Apply to the entire face, neck, and décolleté, avoiding the eye area, in the morning. Use only as directed. Apply liberally to the entire face in the morning or 15 minutes prior to sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor
- Apply to clean face with fingertips or brush and blend well. Layer for additional coverage as needed.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. – 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses.
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Inactive Ingredients
Water (Aqua, Eau), Caprylic/ Capric Triglyceride, Coco-Caprylate, Glycerin, Glyceryl Behenate, Coco-Glucoside, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Glyceryl Caprylate, Sodium Stearoyl Glutamate, Parachlorella Beijerinckii Exopolysaccharides, Chlorella Vulgaris Extract, Lactococcus Ferment Lysate, Alteromonas Ferment Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Microcrystalline Cellulose, Polyglyceryl-3 Polyricinoleate, Xanthan Gum, Butylene Glycol, Isostearic Acid, Caprylhydroxamic Acid, Algin, Calcium Alginate, Propanediol, Maltodextrin, Lactic Acid, Sodium Benzoate, Sodium Chloride.
- Other Information
- Questions
- Principal Display Panel - 10 mL Box Label
- Principal Display Panel - 50 mL Box Label
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INGREDIENTS AND APPEARANCE
ALIVE PREBIOTIC BALANCING MOISTURIZER SPF 15
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71047-262 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.1365 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCO-CAPRYLATE (UNII: 4828G836N6) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) COCO GLUCOSIDE (UNII: ICS790225B) JOJOBA OIL (UNII: 724GKU717M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOSTEARIC ACID (UNII: X33R8U0062) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) SODIUM ALGINATE (UNII: C269C4G2ZQ) CALCIUM ALGINATE (UNII: 8P20S56HZI) PROPANEDIOL (UNII: 5965N8W85T) MALTODEXTRIN (UNII: 7CVR7L4A2D) CHLORELLA VULGARIS (UNII: RYQ4R60M02) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71047-262-50 1 in 1 BOX 09/14/2018 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71047-262-10 1 in 1 BOX 09/14/2018 2 10 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 not final part352 09/14/2018 Labeler - Algenist, LLC (080380765)