Otc - Active Ingredient
Active Ingredients Purpose
Zinc Oxide 19% Sunscreen
Amavara Transparent Mineral Sunscreen Spf30
FDA Label NDC 71942-101
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 Spf30 (NDC 71942-101). 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 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.
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
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, Fragrance, Benzylidene Dimethoxydimethylindanone, Cerium Oxide, Aluminum Oxide, Zingiber Officinale (Ginger) Root Extract
Package Label.Principal Display Panel
Transparent Mineral Sunscreen Lotion
3.0 Fl Oz. 88.7mL
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