Premium Moisturizing Sunscreen Spf 50 Spray
FDA Label NDC 69039-234
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sun Bum Llc for the product Premium Moisturizing Sunscreen Spf 50 (NDC 69039-234). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Avobenzone 3%, Homosalate 15%,
Octisalate 5%, Octocrylene 7%
Purpose
Sunscreen
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
Warnings
For external use only
Flammable: do not use near heat, flame, or while smoking
Do Not Use
on damaged or broken skin
When Using This Product
• keep out of eyes. Rinse with water to remove.
• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Stop Use And Ask A Doctor
if rash occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
• shake well before use • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in wellventilated area. 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 time in the sun, especially from 10 a.m.- 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
protect this product from excessive heat and direct sun
Inactive Ingredients
alcohol denat. (54%), C12-15 alkyl benzoate, acrylates/octylacrylamide copolymer, dicaprylyl carbonate, PPG-5-ceteth-20, fragrance, tocopherol
Questions?
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