Otc - Active Ingredient
Methoxy cinnamic acid ethylhexyl ester 7.5%
Diethanolamine hydroxybenzyl benzoate 3.5%
Octyl methoxycinnamate 1.5%
Titanium dioxide 2.7%
Ultra Sunscreen Emulsion
FDA Label NDC 85448-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangsu Senwo Medical Technology Co., Ltd. for the product Ultra Sunscreen (NDC 85448-003). 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
Sunscreen
Indications & Usage
Soothing + Moisturizing
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 product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.
Dosage & Administration
Shake well.
Apply liberally 15 minutes before sun exposure.
Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, 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 asunscreen with a Broad Spectrum SPF value of 15 or higher and other sunprotection measures including: limit time in the sun, especially from 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.
Inactive Ingredient
Water, Glycerin, Methylpropanediol, Dibutyl Adipate, Alcohol, Ammonium PolyacryloyldimethylTaurate, Octyldodecyl Neopentanoate, 1,2-Hexanediol, Hydroxyacetophenone, Olive OilPolyglyceryl-6 Esters, Sorbitan Sesquioleate, Trideceth-10, Polyglyceryl-2Dipolyhydroxystearate, Polyglyceryl-6 Oleate, Sodium Polyacryloyldimethyl Taurate, C13-16Isoparaffin, Bisabolol, Polyglyceryl-10 Myristate, Fragrance, Allantoin, Polyglyceryl-3 Distearate,Aluminum Hydroxide, Stearic Acid, Hydrolyzed Sodium Hyaluronate, Butylene Glycol, 1.2-Pentanediol, Bacillus/Soybean Ferment Extract, Folic Acid, Sodium Hyaluronate
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Label (Label)
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