Active Ingredient
Zinc Oxide 18%
Sunscreen Lotion
FDA Label NDC 82516-202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by True Botanicals for the product Sunscreen (NDC 82516-202). 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, when using product, stop use and ask doctor, keep out of reach of children, inactive ingredients, 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, decreases the risk of sun cancer and early signs of aging caused by the sun
Warnings
For external use only
When Using Product
keep out of eyes.
Rinse with water to remove.
Stop Use And Ask Doctor
if rash occurs
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
aloe barbadensis leaf juice, squalane, polyglyceryl-3
diisostearate, caprylic/capric triglyceride, glyceryl caprylate,
polyhydroxystearic acid, sesamum indicum (sesame) seed
oil, sodium chloride, silybum marianum (milk thistle) ethyl
ester, pisum sativum (pea) peptide, terminalia chebula fruit
extract, rubus idaeus (raspberry) seed oil, niacinamide,
glycerin, sclerotium gum, caprylhydroxamic acid, allantoin,
leuconostoc/radish root ferment filtrate, tocopherol.
May Contain: titanium dioxide, iron oxides
Other Information
Protect the product in this container from excessive heat and direct sun.
Questions Or Comments
Call 1-888-416-0870 M-F 9am-5pm EST
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