Active Ingredients
Zinc Oxide 14%
Sunscreen
FDA Label NDC 81757-002
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 81757-002). 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 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 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.
- Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 degrees F.
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: after 80 minutes of swimming or sweathing
- immediately after towel drying
- at least 2 every 2 hours
- Spray on hands and apply to face
- use in well-ventilated area
- do not inhale
- children under 6 months: ask a doctor
- limit time in the sund, especially from 10a.m. - 2 p.m.
- wear long sleeved shirts, pants, hats and sunglasses
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 Broad Spectrum value of 15 or higher along with other sun protection measures including:
Other Information
- Protect this product from excessive heat and direct sun
- may stain some fabrics
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid , Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cellulose Gum, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Helianthus Annuus (Sunflower) Oil, Jojoba Esters, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Tocopherol, Water.
Questions Or Comments?
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Package Label.Principal Display Panel
28033 (28033)
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