Otc - Active Ingredient
HOMOSALATE 6.0%
OCTISALATE 4.5%
OCTOCRYLENE 5.0%
TITANIUM DIOXIDE 0.52688%
ZINC OXIDE 10.386%
The following Structured Product Label (SPL) was submitted to the FDA by Picton Co., Ltd. for the product Tocobo Blur Finish Sun Cushion Cotton Blue (NDC 85287-513). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
HOMOSALATE 6.0%
OCTISALATE 4.5%
OCTOCRYLENE 5.0%
TITANIUM DIOXIDE 0.52688%
ZINC OXIDE 10.386%
SUNSCREEN
• 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
For external use only
• on damaged skin or broken skin
• keep out of eyes. Rinse with water to remove.
and ask a doctor if • rash occurs
If swallowed, get medical help or contact a Poison Control Center right away.
■ apply liberally 15 minutes before sun exposure.
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 Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
■ children under 6 months of age: Ask a doctor
■ reapply at least every 2 hours
■ use a water-resistant sunscreen if swimming or sweating
■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Water, Silica, Butyloctyl Salicylate, Butylene Glycol, Cyclopentasiloxane, Ethylhexyl Methoxycrylene, Benzotriazolyl Dodecyl p-Cresol, Methyl Methacrylate Crosspolymer, Lauryl PEG-8 Dimethicone, Vinyl Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Disteardimonium Hectorite, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, 1,2-Hexanediol, Magnesium Sulfate, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Fragrance (Parfum), Polyhydroxystearic Acid, Stearic Acid, Isododecane, Octyldodecanol, Caprylyl Glycol, Glyceryl Caprylate, Chamomilla Recutita (Matricaria) Flower Oil, Lactobacillus Ferment Lysate, Isostearic Acid, Lecithin, Polyglyceryl-4 Isostearate, Polyglyceryl-3 Polyricinoleate, Isopropyl Titanium Triisostearate, Aluminum Hydroxide, Tocopherol, Glycerin, Epilobium Fleischeri Extract, Potassium Sorbate, Citric Acid, Gossypium Herbaceum (Cotton) Seed Extract
* Please review the disclaimer below.