Otc - Active Ingredient
Octyl Methoxycinnamate 7.5%
Zinc Oxide 5%
Titanium Dioxide 5%
Foundation Medium Spectrum Liquid
FDA Label NDC 84958-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Bo Win Trade Co., Ltd. for the product Foundation Medium Spectrum (NDC 84958-002). 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, otc - keep out of reach of children, indications & usage, warnings, otc - when using, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
lf swallowed, contact a physician orpoison control center right away.
Indications & Usage
helps prevent sunbum
if used as directed with other sunprotection measures (see Directions)decreases the risk of skin cancer andearly skin aging caused by the sun
Warnings
For external use only
Otc - When Using
When using this product keep out ofeyes. Rinse with water to remove.
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Dosage & Administration
Apply liberally and evenly 15 minutesbefore sun exposure
Reapply at least every two hours
Use a water-resistant sunscreen ifswimming or sweating
Sun Protection Measures. Spendingtime in the sun increases your risk ofskin cancer and early skin aging.Todecrease this risk, regularly use asunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sunprotection measures including:- Limit time in the sun, especially from10 a.m.- 2 p.m.-Wear long-sleeved shirts, pants, hatsand sunglasses
children under 6 months of age:Ask a doctor
Inactive Ingredient
Quaternary ammonium compounds
ISOPROPYL PALMITATE
Dimethyl cyclosiloxane
SILICA
PEG-10 Dimethicone
SORBITAN SESQUIOLEATE
MAGNESIUM STEARATE
Methacrylic acid
WATER
GLYCERIN
Propylene glycol
sodium chloride
Erythritol
CI 77492
CI 77491
CI 77499
Sorbitol powder
Aloe Vera Extract
2-phenoxyethanol
Poly(vinyl alcohol)
Ethyl cellulose
Package Label.Principal Display Panel
Label2 (Label2)
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