Otc - Active Ingredient
Active Ingredients Purpose
Octinoxate 7.5% Sunscreen
Zinc Oxide 10.1% Sunscreen
Skin Soothing Mineral Sunscreen Broad Spectrum Spf 40
FDA Label NDC 75936-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Taylor James, Ltd. for the product Skin Soothing Mineral Sunscreen Broad Spectrum Spf 40 (NDC 75936-129). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
Otc - Keep Out Of Reach Of Children
· Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.
Indications & Usage
· Stop use and ask a doctor if rash occurs
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.
Dosage & Administration
Directions
Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating
-Children under 6 months: Ask a doctor
-Reapply 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 this risk, regularly use a sunscreen
with broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
· Use a water resistant sunscreen if swimming or sweating
Inactive Ingredient
Inactive ingredients Water, Ethylhexyl Stearate, Cyclopentasiloxane, Propanediol, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isohexadecane, Cetearyl Alcohol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Triethoxycaprylylsilane, Squalane, Xanthan Gum, Helianthus Annuus (sunflower) Seed Oil, Trisodium Ethylenediamine Dissucinate, Chlorphenesin, Ethylhexylglycerin, Oleth-3 Phosphate, Punica Granatum Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Polysorbate 60, Citric Acid, Camellia Sinensis Leaf Extract, Olea Europaea (Olive) Fruit extract, Euterpe Oleracaea Fruit Extract, Methylisothiazolinone, Tocotrienols
Package Label.Principal Display Panel
Supergoop Skin Soothing Mineral Sunscreen
with Olive Polyphenols
Broad Spectrum SPF 40
2.4 fl. oz./ 71 mL
* Please review the disclaimer below.
