AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50  EARTHWELL ZINC TECHNOLOGY, REEF SAFE- zinc oxide lotion 
Amavara, Inc

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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AMAVARA® TRANSPARENT MINERAL SUNSCREEN LOTION SPF50
EARTHWELL® ZINC TECHNOLOGY, REEF SAFE

Drug Facts

Active Ingredients

Zinc Oxide 22.5%

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. Retains SPF after 80 minutes activity in the water, sweating or perspiring. Provides high protection against sunburn.

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 ask a doctor if

  • rash occurs or iritation develops and lasts.

Keep out of reach of children

  • If Product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Polyglyceryl-3 Sorbityl Linseedate, Dimethicone, Caprylic/Capric Triglyceride, Mica, Cetyl Dimethicone, Silica, Polyhydroxystearic Acid, Phenyl Caprylic/Capric Triglyceride , Silica, Phenyl Trimethicone, Sodium Chloride, Hydroxyacetophenone, Iron Oxides, CI 77492, Disteardimonium Hectorite, 1,2 Hexanediol , Caprylyl Glycol,Polymethylmethacrylate, Tocopheryl Acetate, Iron Oxides (CI 77499, CI 77491, CI 77492), Glycerin, Bisabolol, Triethyl Citrate, Acrylates/Dimethicone Copolymer, Benzylidene Dimethoxydimethylindanone, Iron Oxides, Cerium Oxide, Aluminum Oxide, Zingiber Officinale (Ginger) Root Extract

PRINCIPAL DISPLAY PANEL - 49 mL Tube Label

AMAVARA®

REEF SAFE

SPF 50

+ EarthWell® Zinc Technology
Tinted Mineral Sunscreen

Safe for Sensitive Skin
Broad Spectrum SPF 50
Water Resistant (80 Minutes)

1.65 FL. OZ. / 49 mL

Reef Safe

Cruelty Free

Child Friendly

Dry Grip

PRINCIPAL DISPLAY PANEL - 49 mL Tube Label
AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50   EARTHWELL ZINC TECHNOLOGY, REEF SAFE
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71942-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE225 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GINGER (UNII: C5529G5JPQ)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MICA (UNII: V8A1AW0880)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
WATER (UNII: 059QF0KO0R)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CERIC OXIDE (UNII: 619G5K328Y)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
LEVOMENOL (UNII: 24WE03BX2T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71942-102-0170 mL in 1 BOX; Type 0: Not a Combination Product02/10/2018
2NDC:71942-102-0449 mL in 1 TUBE; Type 0: Not a Combination Product04/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/10/2018
Labeler - Amavara, Inc (079636282)
Establishment
NameAddressID/FEIBusiness Operations
Northwest Cosmetic Laboratories LLC929572014manufacture(71942-102)

Revised: 4/2019
Document Id: f5854150-d394-4ebb-8031-1a5862aa8ac2
Set id: 64a596f5-141d-5119-e053-2991aa0a8d97
Version: 3
Effective Time: 20190416
 
Amavara, Inc