HOMOSALATE, OCTISALATE
HOMOSALATE, OCTISALATE is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including SUMMER GELEE SPF-4, Tan De Soleil Orange Tanning Balm SPF 6, Fruit of the Earth Sun Town City Dark Tanning Dry Oil SPF 8 Sunscreen. Available dosage forms: gel, oil, spray, aerosol, spray.
Drug Details
- Generic Name
- HOMOSALATE, OCTISALATE
- Brand Names
- SUMMER GELEE SPF-4, Tan De Soleil Orange Tanning Balm SPF 6, Fruit of the Earth Sun Town City Dark Tanning Dry Oil SPF 8 Sunscreen, FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN
- Application Number
- M020
- Sponsor
- SUMMER GELEE LLC
- NDC Codes
- 4
- Dosage Forms
- GEL, OIL, SPRAY, AEROSOL, SPRAY
- Routes
- TOPICAL
- Active Ingredients
- HOMOSALATE, OCTISALATE
Indications and Usage
Drug Facts Active Ingredients Active Ingredients Purpose Avobenzone 3.0%............. Sunscreen Homosalate 6.8% ............. Sunscreen Octisalate 5.0%................ Sunscreen Octocrylene 10.0% ........... Sunscreen Uses ■ helps prevent sunburn ■ higher SPF gives more sunburn protection ■ provides high protection against sunburn ■ retains SPF after 40 minutes of perspiring ■ 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 occurs. 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: ■ at least every 2 hours ■ after 40 minutes of swimming or sweating ■ Children under 6 months of age: 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 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. Other Information ■ Protect this product from excessive heat and direct sun. Inactive Ingredients Water, Butyloctyl Salicylate, Silica, Dimethicone, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Glyceryl Stearate, PEG-100 Stearate, Isododecane, Glycerin, Bisabolol, Propanediol, Steareth-21, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Dipotassium Glycyrrhizate, Squalane, Beta-Glucan, Melanin, Cetearyl Glucoside, Steareth-2, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates Copolymer, Polymethyl Methacrylate, Disodium EDTA, Ethyl Ferulate, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Pentylene Glycol, 1,2-Hexanediol, Fragrance, Iron Oxides.
Warnings
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 occurs. Keep out of reach of children. ■ If swallowed, get medical help or contact a Poison Control Center right away.