Alive Prebiotic Balancing Moisturizer SPF15

Alive Prebiotic Balancing Moisturizer SPF 15 by

Drug Labeling and Warnings

Alive Prebiotic Balancing Moisturizer SPF 15 by is a Otc medication manufactured, distributed, or labeled by Algenist, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALIVE PREBIOTIC BALANCING MOISTURIZER SPF 15- zinc oxide lotion 
Algenist, LLC

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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Alive Prebiotic Balancing Moisturizer SPF15

Active Ingredients

Zinc Oxide 13.65%

Purpose

Sunscreen

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

For external use only

  • Do not use on damaged or broken skin

  • When using this product keep out of eyes. Rinse with water to remove

  • Stop use and consult 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.

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.

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

Protect this product from excessive heat and direct sun.

Questions

Call toll free 1-877-650-1837

Principal Display Panel - 10 mL Box Label

ALIVE

Prebiotic Balancing
Moisturizer SPF 15

Soin Prébiotique
Équilibrant FPS 15

Broad Spectrum
Sunscreen SPF 15

Écran Solaire Large
Spectre FPS 15

ALGENISTAlguronic Acid + Prebiotic

Principal Display Panel

ALIVE PREBIOTIC BALANCING MOISTURIZER SPF 15 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71047-364
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.1365 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71047-364-501 in 1 BOX09/14/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 71047-364-101 in 1 BOX09/14/2018
210 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/14/2018
Labeler - Algenist, LLC (080380765)

Revised: 11/2022
Document Id: ec975b32-5eb4-3575-e053-2995a90a6780
Set id: 1a931ddc-d865-4bdf-a3d6-b5fa349ff5ea
Version: 4
Effective Time: 20221103
 
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