Sun Bum Mineral Sunscreen Roll On Spf 50
FDA Label NDC 69039-641
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sun Bum Llc for the product Sun Bum Mineral Sunscreen Roll On Spf 50 (NDC 69039-641). 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 if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Titanium dioxide 3.4%, Zinc oxide 16%
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
Do Not Use
on damaged or broken skin
When Using This Product
keep out of eyes. Rinse with water to remove.
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 • apply liberally and spread by hand15 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 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
water, butyloctyl salicylate, dicaprylyl carbonate, isononyl isononanoate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, bisabolol, bentonite, cellulose gum, C18-21 alkane, caprylyl glycol, citric acid, coco-glucoside, glycerin, microcrystalline cellulose, polyhydroxystearic acid, sodium gluconate, sodium stearoyl glutamate, tocopherol, polyester-8, silica, alumina, caprylhydroxamic acid
Questions?
1-877-978-6286
Package Labeling:
Bottle2 (Bottle2)
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