AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50

Manufacturer
Amavara, Inc | Northwest Cosmetic Laboratories LLC
Effective date
2019-04-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:23

Label at a glance#

ProductAMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50 EARTHWELL ZINC TECHNOLOGY, REEF SAFE
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

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 spectr...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only. Do Not Use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs or iritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 49 mL Tube Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71942-102-01AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50 EARTHWELL ZINC TECHNOLOGY, REEF SAFE70 mL in 1 BOXLOTION703
71942-102-04AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50 EARTHWELL ZINC TECHNOLOGY, REEF SAFE49 mL in 1 TUBELOTION493

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71942-102AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50 EARTHWELL ZINC TECHNOLOGY, REEF SAFE (ZINC OXIDE) LOTION [AMAVARA, INC]3Legacy NDC, 2 package rows20190502_64a596f5-141d-5119-e053-2991aa0a8d97.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71942-10271942-102-01, 71942-102-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f5854150-d394-4ebb-8031-1a5862aa8ac264a596f5-141d-5119-e053-2991aa0a8d972019-04-16WarningsExact identifier
spl id: f5854150-d394-4ebb-8031-1a5862aa8ac2
spl set id: 64a596f5-141d-5119-e053-2991aa0a8d97

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.