Active Ingredient
Zinc Oxide 21.6%
Topco Topcare Everyday Mineral Sunscreen Zinc Oxide Spf 50 Lotion
FDA Label NDC 36800-251
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topco Topcare Everyday Mineral Sunscreen Zinc Oxide Spf 50 (NDC 36800-251). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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
Purpose
Sunscreen
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
For external use only
Do Not Use
- on damaged or broken skin.
When Using This Product
- keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor If
- rash occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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 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 Information
- protect the product in this container from excessive heat and direct sun
- may stain or damage some fabrics, materials or surfaces
Inactive Ingredients
water, C12-15 alkyl benzoate, caprylic/capric triglyceride, styrene/acrylates copolymer, octydodecyl citrate crosspolmyer, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, glycerin, polyhydroxystearic acid, ethyl methicone, cetyl dimethicone, silica, chrysanthemum parthenium (feverfew) flower/leaf/stem juice, glyceryl behenate, phenethyl alcohol, caprylyl glycol, bis-divinyl dimethicone/PEG-10 dimethicone crosspolymer, sodium chloride, phenoxyethanol, chlorphenesin
Package Label.Principal Display Panel
Top48146a (Top48146a)
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