Otc - Active Ingredient
Active ingredie:
Zinc Oxide 5.5%.
Os-01 Lip Spf Bs Spf15 Cream
FDA Label NDC 84451-004
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 Lip Spf Bs Spf15 (NDC 84451-004). 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 Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Warnings
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 eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a 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
Directions:
• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water-resistant sunscreen If swimming or sweating.
• Children under 8 months of age: Ask a Doctor.
• Sun Probation 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 Safety Information
Other information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
Inactive Ingredients
Simmondsia Chinensis (Jojoba) Seed Oil, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl
Palmitate, Butyl octyl Salicylate. Caprylic/Capric Triglyceride, Water (Aqua), Garcinia Indica Seed Butter, Tocopheryl Acetate, Butylene/Ethylene/Styrene Copolymer, Glyceryl Oleate, Glyceryl Dioleate, Glycerin, Oleic Acid, Tribehenin, Sorbitan Isostearate, Palmitoyl Tripeptide-1, Dipalmitoyl Hydroxyproline, Trihydroxystearin, Sodium Hyaluronate, Glucomannan, Tetrahexyldecyl Ascorbate, Bisabolol, Decapeptide-52*,Ethylhexylglycerin, Caprylyl/Capryl Glucoside, Propanediol, Ectoin, Centella Asiatica Extract, Hippophae Rhamnoides oil, Helianthus Annuus (Sunflower) Seed Oil, Copernicia Cerifera (Carnauba)Wax, Tocopherol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxy stearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Beta-Sitosterol, Squalene, Lactic Acid, Palmitic acid.
Package Label.Principal Display Panel
Os-01 Lip Spf (Os01lipspf)
* Please review the disclaimer below.
