Otc - Active Ingredient
Active ingredients – Zinc Oxide 17.5 %
Os-01 Face Spf Bs Spf30 Tinted Cream
FDA Label NDC 84451-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oneskin Inc. for the product Os-01 Face Spf Bs Spf30 Tinted (NDC 84451-002). 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, 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.
Label Section Quick Index
Otc - Purpose
Purpose – Sunscreen
Indications & Usage
Uses –
Helps prevent sunburn
If used as directed with other sun protection measures (See direction), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Warning – For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eye. Rinse with water to remove.
Otc - Stop Use
Stop use and ask doctor if rash occurs
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.
Dosage & Administration
Direction-
Apply liberally 15 minutes before sun exposure.
Reapply at least every two hours.
Use a water-resistant sunscreen if 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 the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including:
Limit time in the sun. especially from 10 am to 2 pm
Wear long-sleeved shirts, pants hats and sunglasses.
Other Safety Information
Other information:
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
Inactive ingredients:
Water(aqua), Caprylic/Capric Triglyceride, Glycerin, Methyl Dihydroabietate, Cetearyl Alcohol, Cetyl Palmitate, Coco-Glucoside, Caprylyl/Capryl Glucoside, Sorbitan Palmitate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Nut Extract, Ethyl Ferulate, Bisabolol, Allantoin, Hydrolyzed Jojoba Esters, Acacia Senegal Gum, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Decapeptide-52*, Oryza Sativa (rice) Starch,Camellia Sinensis Leaf Extract, Euterpe Oleracea Fruit Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Xanthan Gum, Sodium Phytate, Propylene Glycol, Phenoxyethanol, sodium Benzoate, Potassium Sorbate, Triethoxycaprylylsilane, Alumina, Magnesium Oxide, Iron Oxides (CI 77491, CI 77492, CI77499)
* Please review the disclaimer below.
