Otc - Active Ingredient
Active ingredients Purpose
Zinc Oxide 22.5% Sunscreen
Amavara Transparent Mineral Sunscreen Spf50
FDA Label NDC 71942-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amavara, Inc for the product Amavara Transparent Mineral Sunscreen Spf50 (NDC 71942-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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