Active Ingredient
Zinc oxide 8%
The following Structured Product Label (SPL) was submitted to the FDA by Sun Bum Llc for the product Sun Bum Mineral Spf30 Sunscreen (NDC 69039-275). 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.
Zinc oxide 8%
Sunscreen
• 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
For external use only
damaged or broken skin
• keep out of eyes. Rinse with water to remove.
if rash occurs
If swallowed, get medical help or contact a Poison Control Center immediately.
• 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
• protect this product from excessive heat and direct sun
prunus amygdalus dulcis (sweet almond) oil, cera alba (beeswax), simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, fragrance, argania spinosa kernel (argan) oil, caprylic/capric triglyceride, tocopheryl acetate, copernicia cerifera (carnauba) wax, tocopherol, glycine soja (soybean) oil, glyceryl caprylate, bisabolol, polyhydroxystearic acid, polyglyceryl-3-polyricinoleate, isostearic acid, lecithin, glyceryl undecylenate
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