Otc - Active Ingredient
Active ingredients – Zinc Oxide 14 %
Os-01 Body Spf 30 Cream
FDA Label NDC 84451-001
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 Body Spf 30 (NDC 84451-001). 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 after 80 minutes of swimming or sweating.
immediately after towel drying, at least every 2 hours
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
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
Inactive Ingredients: Caprylic/Capric Triglyceride 40 - 65 Butyloctyl Salicylate, C13-15 Alkane, Stearalkonium Hectorite,Coconut Alkanes, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Wax, Propylene Carbonate, Quaternium-90 Bentonite, Butyrospermum Parkii Nut Extract, Decapeptide-52, Camellia Oleifera (Tea) Seed Oil, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius Seed Oil, Lactobacillus/Acerola Cherry Ferment, Coco-Caprylate/Caprate, Ceramide NP, Ceramide AP, Ceramide EOP, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate , Carbomer, Xanthan gum, Water, Propylene Glycol ,Triethyl Citrate, Citric Acid, Sodium Benzoate, Phenoxyethanol.
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