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

AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50 by

Drug Labeling and Warnings

AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50 by is a Otc medication manufactured, distributed, or labeled by Amavara, Inc, Northwest Cosmetic Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71942-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	225 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71942-102-01	70 mL in 1 BOX; Type 0: Not a Combination Product	02/10/2018
2	NDC: 71942-102-04	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	02/10/2018

Labeler - Amavara, Inc (079636282)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Laboratories LLC		929572014	manufacture(71942-102)