Label: AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF30 EARTHWELL ZINC TECHNOLOGY, REEF SAFE- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71942-101-01, 71942-101-03 - Packager: Amavara, 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 April 16, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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. Retains SPF after 80 minutes activity in the water, sweating or perspiring. Provides high protection against sunburn.
- Warnings
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Directions
Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours
- Children under 6 months of age, ask doctor
- Reapply :
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least after every 2 hours
- 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 value of 15 or higher and other sun protection measures including
- limit your time in the sun, especially from 10 a.m.-2 p.m.
- Wear long sleeved shirts, pants, hats, and sunglasses.
- Other Information
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Inactive Ingredients
Water, Butyloctyl Salicylate, Polyglyceryl-3 Sorbityl Linseedate, Styrene/Acrylates Copolymer, Dimethicone, Cetyl Dimethicone, Caprylic/Capric Triglyceride , Silica, Phenyl Trimethicone, Polyhydroxystearic Acid, Sodium Chloride, Caramel, Hydroxyacetophenone, Disteardimonium, Hectorite, 1,2-Hexanediol , Caprylyl Glycol, Polymethylmethacrylate, Tocopheryl Acetate, Triethyl Citrate, Glycerin, Bisabolol, Acrylates/Dimethicone Copolymer, Benzylidene Dimethoxydimethylindanone, Cerium Oxide, Aluminum Oxide, Zingiber Officinale (Ginger) Root Extract
- PRINCIPAL DISPLAY PANEL - 49 mL Tube Label
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INGREDIENTS AND APPEARANCE
AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF30 EARTHWELL ZINC TECHNOLOGY, REEF SAFE
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71942-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 190 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALUMINUM OXIDE (UNII: LMI26O6933) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) GLYCERIN (UNII: PDC6A3C0OX) GINGER (UNII: C5529G5JPQ) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L) CERIC OXIDE (UNII: 619G5K328Y) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CARAMEL (UNII: T9D99G2B1R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DIMETHICONE (UNII: 92RU3N3Y1O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LEVOMENOL (UNII: 24WE03BX2T) WATER (UNII: 059QF0KO0R) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71942-101-01 88.7 mL in 1 BOX; Type 0: Not a Combination Product 02/09/2018 2 NDC:71942-101-03 49 mL in 1 TUBE; Type 0: Not a Combination Product 04/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/09/2018 Labeler - Amavara, Inc (079636282) Establishment Name Address ID/FEI Business Operations Northwest Cosmetic Laboratories LLC 929572014 manufacture(71942-101)