Active Ingredients
Homosalate 15%
Octisalate 5%
Zinc Oxide 4%
Sunscreen
FDA Label NDC 81757-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Imperfect Foods for the product Sunscreen (NDC 81757-001). 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, otc - purpose, warnings, do not use, ask a doctor, when using, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
Ask A Doctor
Stop use and ask a doctor if rash develops
When Using
When using this product keep out of eyes. Rinse with water to remove.
Keep Out Of Reach Of Children
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: use a water resistant sunscreen if swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months: ask a doctor
Other Information
- Protect this product from excessive heat and direct sun
- may stain some fabrics
Inactive Ingredients
Water (Aqua), Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, Cetearyl Alcohol, Phenoxyethanol, C13-14 Isoparaffin, Caprylyl Glycol, Cyclotetrasiloxane, Lauroyl Lysine, Ethylhexylglycerin, Polyhydroxystearic Acid, Hexylene Glycol, Laureth-7, Allantoin, Dimethiconde/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Triethoxycaprylylsilane.
Questions Or Comments?
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Package Label.Principal Display Panel
28032 (28032)
SPF 15 Face Lotion NDC: 81757-001-04
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