Otc - Active Ingredient
Active ingredients Purpose: Sunscreen
Avobenzone 3%, Homosalate 10%,
Octisalate 5%, Octocrylene 10%
Premium Moisturizing Sunscreen Broad Spectrum Spf 50 Lotion
FDA Label NDC 44717-069
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wasatch Product Development, Llc for the product Premium Moisturizing Sunscreen Broad Spectrum Spf 50 (NDC 44717-069). 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, other safety information, inactive ingredient, 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
- 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
Dosage & Administration
Directions
- shake well before use
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- 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 10a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
Other Safety Information
Protect this product from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients
water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, dimethicone, polyester-8, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin, trimethylsiloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium EDTA, methylisothiazolinone
Package Label.Principal Display Panel
Sun Bum
50
Premium Moisturizing Sunscreen Lotion
Broad Spectrum SPF 50
Water Resistant (80 Minutes)
Gluten Free and Vegan
Antioxidant Enriched (Vitamin E)
Dermatologist Tested
6 FL OZ / 177 mL
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