Summer Face Sunscreen Spf 50 Liquid
FDA Label NDC 84281-893
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Summer Gelee Llc for the product Summer Face Sunscreen Spf 50 (NDC 84281-893). 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 drug facts, active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Avobenzone 3.00%
Homosalate 10.00%
Octisalate 5.00%
Octocrylene 7.5%
Purpose
Sunscreen
Uses:
• Helps prevent sunburn. • Higher SPF gives moresunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • 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.
When Using This Product
keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor
- if rash or irritation develops and lasts.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions:
Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: ask a doctor. • 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 the 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 10am-2pm. • Wear long-sleeved shirts, pants, hats, & sunglasses.
Other Information:
Protect the product in this container from excessive heatand direct sun.
Inactive Ingredients:
1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Brassica Napus (Rapeseeds) Glycerides, Butylene Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Methicone, Cetearyl Olivate, Decyl Glucoside, Dodecane, Ethylhexylglycerin, Glycerin, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Oryza Sativa (Rice) Bran Extract, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Stearate, Tetrasodium EDTA, Tocopherol, Water (Aqua)
Package Labeling:
Label (Label)
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