Amavara®

Amavara®
SPL v3
SPL
SPL Set ID 64a596f5-141d-5119-e053-2991aa0a8d97
Route
TOPICAL
Published
Effective Date 2019-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (225 mg)
Inactive Ingredients
1,2-hexanediol Caprylyl Glycol Cetyl Dimethicone 25 Aluminum Oxide Ginger Butyloctyl Salicylate Mica Disteardimonium Hectorite Glycerin Triethyl Citrate Phenyl Trimethicone Sodium Chloride Hydroxyacetophenone Water Polyhydroxystearic Acid (2300 Mw) Medium-chain Triglycerides .alpha.-tocopherol Acetate Ceric Oxide Ferric Oxide Yellow Ferric Oxide Red Ferrosoferric Oxide Dimethicone Silicon Dioxide Benzylidene Dimethoxydimethylindanone Styrene/acrylamide Copolymer (500000 Mw) Poly(methyl Methacrylate; 450000 Mw) Levomenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-02-10

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.
Warnings

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

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 22.5%

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

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 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


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.
Purpose

Sunscreen

Warnings

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

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 22.5%

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

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 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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)