Active Ingredients
Ethyl Alcohol 62%
Avobenzone 3%, Homosalate 10%,
Octocrylene10%, Octisalate 5%
Spf30 Sunscreen And Antibacterial Hand Sanitizer Kit
FDA Label NDC 70412-817
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Ayan Biotech Co., Ltd. for the product Spf30 Sunscreen And Antibacterial Hand Sanitizer (NDC 70412-817). 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
Antiseptic
Sunscreen
Uses
•Hand sanitizer to help decrease bacteria on the skin. When water, soap & towel are not available. Recommended for repeated use.
• Helps prevent sunburn
Warnings:
For external use only.
Flammable. Keep away from fire or flame.
Do not apply around eyes,
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn NOT skin cancer or early skin aging. This product is NOT water resistant or sweat resistant.
For external use only.
Do Not Use
in ears & mouth.
on damaged or broken skin.
When Using This Product
avoid contact with eyes. In case of contact flush eyes with water.
keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor
if redness or irritation develop and persist for more than 72 hours.
if rash occurs.
Keep Out Of Reach Of Children.
Children must be supervised in use of this product.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Squirt as needed into your palms and thoroughly spread on both hands. Rub into skin until dry
Non-Water Resistant Product
• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
•Limit time in the sun, especially from 10 a.m. to 2 p.m.
•Wear long sleeve shirts, pants, hats and sunglasses.
Inactive Ingredients.
water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, carbomer, fragrance.
Water, Glycerin, Potassium Phosphate, VP/Hexadecene Copolymer, Dimethicone, Phenoxyethanol, Acrylates/Beheneth-25 Methacrylate Copolymer, Caprylyl Glycol, Bisabolol, Fragrance, Triethanolamine, Disodium EDTA
Other Information
Store at room temperature 15°C to 30°C (59° F to 86° F)
•Protect this product from excessive heat and direct sun
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