Active Ingredient
Zinc oxide 19.2%
Baby Bum Mineral Spf50 Sunscreen
FDA Label NDC 69039-271
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 Baby Bum Mineral Spf50 Sunscreen (NDC 69039-271). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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 right away.
Directions
• 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 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 • keep this outer card for complete labeling information
Inactive Ingredients
cocos nucifera (coconut) oil, persea gratissima (avocado) oil, limnanthes alba (meadowfoam) seed oil, linum usitatissimum (linseed) seed oil, oryza sativa (rice bran) wax, euphorbia cerifera (candelilla) wax, butyloctyl salicylate, copernicia cerifera (carnauba) wax, ozokerite, butyrospermum parkii (shea butter), oryzanol, fragrance, theobroma cacao (cocoa) seed butter, carthamus tinctorius (safflower) seed oil, jojoba esters, tocopherol, bisabolol
Questions?
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