Amavara®

Amavara®
SPL v10
SPL
SPL Set ID 647c15d0-fa50-207d-e053-2a91aa0a9c3e
Route
TOPICAL
Published
Effective Date 2019-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (190 mg)
Inactive Ingredients
Sodium Chloride Caprylyl Glycol Triethyl Citrate Butyloctyl Salicylate Aluminum Oxide Disteardimonium Hectorite Poly(methyl Methacrylate; 450000 Mw) Glycerin Ginger Polyhydroxystearic Acid (2300 Mw) Benzylidene Dimethoxydimethylindanone Ceric Oxide Phenyl Trimethicone Caramel 1,2-hexanediol Dimethicone Medium-chain Triglycerides Silicon Dioxide Hydroxyacetophenone .alpha.-tocopherol Acetate Levomenol Water Cetyl Dimethicone 25 Styrene/acrylamide Copolymer (500000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-02-09
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children

  • If Product is swallowed get medical help or contact a Poison Control Center right away.
Section 50570-1

Do Not Use on damaged or broken skin

Warnings

For external use only.

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.

Active Ingredients

Zinc Oxide 19%

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

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.
Principal Display Panel 49 Ml Tube Label

AMAVARA®

REEF SAFE

SPF 30

+ EarthWell® Zinc Technology

Transparent Mineral Sunscreen

Safe for Sensitive Skin

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

1.65 FL. OZ. / 49 mL

Reef Safe

Cruelty Free

Child Friendly

Dry Grip

Structured Label Content

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children

  • If Product is swallowed get medical help or contact a Poison Control Center right away.
Section 50570-1 (50570-1)

Do Not Use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only.

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.

Active Ingredients

Zinc Oxide 19%

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

When Using This Product (When using this product)
  • Keep out of eyes. Rinse with water to remove
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs or iritation develops and lasts.
Principal Display Panel 49 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 49 mL Tube Label)

AMAVARA®

REEF SAFE

SPF 30

+ EarthWell® Zinc Technology

Transparent Mineral Sunscreen

Safe for Sensitive Skin

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

1.65 FL. OZ. / 49 mL

Reef Safe

Cruelty Free

Child Friendly

Dry Grip

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:48.616908 · Updated: 2026-03-14T22:55:31.631898