FDA Label for Amavara Transparent Mineral Sunscreen Spf50 Earthwell Zinc Technology, Reef Safe
View Indications, Usage & Precautions
Amavara Transparent Mineral Sunscreen Spf50 Earthwell Zinc Technology, Reef Safe Product Label
The following document was submitted to the FDA by the labeler of this product Amavara, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients Purpose
Zinc Oxide 22.5% Sunscreen
Otc - Purpose
Uses
- Helps Prevent sunburn
- Higher SPF gives more sunburn protection
- If used as directed with other sun protection measures ( see directions), decreases the risk of skin care and early skin aging caused by the sun
- Retains SPF after 80 minutes activity in the water, sweating or prespiring
- Provides high protection against sunburn
Otc - Keep Out Of Reach Of Children
Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs or irritation develops and lasts.
Warnings
Warnings
Do not use • on damaged or broken skin.
When using this product: • Keep out of eyes. Rinse with water to remove.
For external use only.
Dosage & Administration
Directions
- Apply liberally and generously 15 minutes before sun exposure and at least
every 2 hours. • Children under 6 months of age: ask a doctor.
•
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 • Reapply:
• after 80 minutes of swimming or sweating • immediately after towel drying
• at least every 2 hours
Inactive Ingredient
Water, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Polyglyceryl-3 Sorbityl Linseedate, Dimethicone, Caprylic/Capric Triglyceride, Cetyl Dimethicone, Silica, Polyhydroxystearic Acid, Phenyl Trimethicone, Sodium Chloride, Mica, 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 (CI 77499), Fragrance, Cerium Oxide, Aluminum Oxide, Zingiber Officinale (Ginger) Root Extract
Package Label.Principal Display Panel
Transparent Mineral Sunscreen Lotion Broad Spectrum SPF50
2.4 Fl. Oz. 70mL
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