Otc - Active Ingredient
HOMOSALATE 5.19%
OCTISALATE 2.25%
OCTOCRYLENE 2.5%
ZINC OXIDE 3.0%
Ultra Soother Dry-touch Sunscreen Cream
FDA Label NDC 87534-150
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skinnplus for the product Ultra Soother Dry-touch Sunscreen (NDC 87534-150). 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
• 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
For external use only
Otc - Do Not Use
• on damaged skin or broken skin
Otc - When Using
• keep out of eyes. Rinse with water to remove.
Otc - Stop Use
and ask a doctor if • rash occurs
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
■ apply liberally 15 minutes before sun exposure.
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 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
■ children under 6 months of age: Ask a doctor
■ reapply at least every 2 hours
■ use a water-resistant sunscreen if swimming or sweating
Other Safety Information
■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Inactive Ingredient
WATER, PROPANEDIOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, COCO-CAPRYLATE/CAPRATE, GLYCERIN, PENTYLENE GLYCOL, 1,2-HEXANEDIOL, CETEARYL OLIVATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, CETEARYL ALCOHOL, GLYCERYL STEARATE, LAUROYL LYSINE, POLYHYDROXYSTEARIC ACID, PANTHENOL, TRIETHOXYCAPRYLYLSILANE, ACRYLATES COPOLYMER, STEARIC ACID, TROMETHAMINE, SPHINGOMONAS FERMENT EXTRACT, NEOPENTYL GLYCOL DIETHYLHEXANOATE, ETHYLHEXYLGLYCERIN, POLYACRYLATE CROSSPOLYMER-6, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, BIOSACCHARIDE GUM-1, CITRIC ACID, ACETYL GLUCOSAMINE, SODIUM HYALURONATE, HYDROXYACETOPHENONE, SODIUM HYALURONATE CROSSPOLYMER, TOCOPHEROL, CAPRYLYL GLYCOL
* Please review the disclaimer below.
