The following Structured Product Label (SPL) was submitted to the FDA by Overlaps Corp. for the product Overlaps Ectoin Moist Sun (NDC 87601-002). 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 otc - active ingredient, otc purpose, uses, do not use, ask doctor, stop use, when using, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active Ingredient Purpose
Avobenzone 2.90% ....................................................................Sunscreen
Homosalate 9.00%........................................................................Sunscreen
Octisalate 4.50%.........................................................................Sunscreen
Octocrylene 5.00%........................................................................Sunscreen
Purpoise-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
Do Not Use
For external use only
Do not use-on damaged skin, on broken skin
Ask Doctor-Stop use and ask a doctor if rash occurs.
Stop use and ask a doctor if rash occurs.
When using this product, keep out of eyes. Rinse with water to remove
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 at least every two 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 spectrumSPF of 15 or higher and other sun protection measures including: 1) limit time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
■ Ask a doctor to use for children under 6 months
Other Information ■ Protect the product in this container from excessive heat and direct sun
Inactive ingredients
Water, Propanediol, Butyloctyl Salicylate, Dibutyl Adipate, Phenethyl Benzoate, Glycerin, Alcohol Denat., Polymethylsilsesquioxane, Polyglyceryl-3 Distearate, 1,2-Hexanediol, Ectoin, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Poly C10-30 Alkyl Acrylate, Tromethamine, Ethylhexylglycerin, Fragrance, Glyceryl Stearate Citrate, Sodium Polyacryloyldimethyl Taurate, Dimethicone, Xanthan Gum, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyglyceryl-10 Myristate, Avena Sativa (Oat) Kernel Extract, Centella Asiatica Extract, Citrus Unshiu Fruit Extract, Houttuynia Cordata Extract, Oryza Sativa (Rice) Bran Extract, Punica Granatum Fruit Extract, Rosa Damascena Flower Extract, Schisandra Chinensis Fruit Extract, Tremella Fuciformis (Mushroom) Extract, Tocopherol, Arginine, Carbomer
Questions or comments? 1-800-545-8856
For external use only
Do not use ■ on damaged skin
■ on broken skin
Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
Principal Display Panel
Overlaps
Ecotin
Moist Sun
Ecotin 0;5%/Rice
Sunscreen Broad Spectrum SPF50
1.69 fl.oz/50 mL
* Please review the disclaimer below.
