Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3 %, Homosalate 10%
Octisalate 5.%, Octocrylene 10% Sunscreen
Sun Bum Face 50 Premium Sunscreen Spf 50 Lotion
FDA Label NDC 44717-080
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 Sun Bum Face 50 Premium Sunscreen Spf 50 (NDC 44717-080). 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
- 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 of 15 or higher and other sun protection measures, including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses.
Other Safety Information
Other information
protect this product from excessive heat and direct sun.
Inactive Ingredient
Inactive Ingredients water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer, dimethicone, polyester-8, tocopherol acetate, BHT, glyceryl stearate, PEG-100 stearate, ethylhexyl stearate, behenyl alcohol, caprylyl methicone, trimethylsiloxysilicate, dimethyl capramide, sodium polyacrylate, xanthan gum, trideceth-6, disodium EDTA, ethylhexylglycerin, polyaminopropyl biguanide, methylisothiazolinone
Package Label.Principal Display Panel
Sun Bum
Face 50
Premium Sunscreen Face Lotion
Broad Spectrum SPF 50
Water Resistant (80 Minutes)
Lightweight
Breakout Free
Fragrance Free, Oxbenzone Free
Dermatologist Tested
Gluten Free
Vegan
3 FL OZ / 88 mL
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