Active Ingredients
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 10%
Black Girl Sunscreen
FDA Label NDC 58443-0415
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises, Inc. for the product Black Girl Sunscreen (NDC 58443-0415). 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 ingredients, 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
Do not use on damaged or broken skin
When Using This Product
When using this product keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor
Stop use and ask a doctor if rash occurs
Keep Out Of Reach Of Children.
Keep out of reach of children. If product is 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
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-sleeved shirts, pants, hats and sunglasses
children under 6 months: Ask a doctor.
Inactive Ingredient
Aloe Vera Leaf Extract, Butyrospermum Parkii (Shea) Butter, Cetyl Ethylhexanoate, Cocoa Nucifera (Coconut) Oil, Diisopropyl Adipate, Diisopropyl Sebacate, Neopentyl Glycol Diethylhexanoate, Silica, Silica Silylate, Squalane, Tocopheryl Acetate, VP/Hexadecene Copolymer
Other Information
Protect this product form excessive heat and direct sun
Principal Display Label - 1.7Oz Black Girl Sunscreen Broad Spectrum Spf 45 Ultra Sheer Sunscreen Gel
Principle Display Label (58443 0415 3)
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