Active Ingredient
Zinc Oxide
Sunscreen Cream
FDA Label NDC 82516-101
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, Inc. for the product Sunscreen (NDC 82516-101). 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 doctor, 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 diercted with other sun protection measures, decreasis the risk of skin cancer and wearly sighs of aging caused by the sun.
Warnings
For external use only
Do Not Use
Do not use on damaged or broken skin
When Using This Product
When using this product keep out of eyes. Rinse with water to remove.
Stop Use And Ask Doctor
Stop use and ask doctor if rash occurs
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away.
Directions
• Apply liberally and evenly as the last
step in your skincare routine, before
makeup and 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if
swimming or sweating: immediately after
towel drying at least every 2 hours.
Inactive Ingredients
camellia sinensis leaf (green tea) water, caprylic/capric
triglyceride, coco-caprylate, glycerin*, polyglyceryl-6
stearate, capryloyl glycerin/sebacic acid copolymer, water,
oryza sativa (rice) bran extract, squalane, polyhydroxystearic
acid, hippophae rhamnoides (seabuckthorn) seed oil*,
silybum marianum (milk thistle) ethyl ester, pisum sativum
(pea) peptide, terminalia chebula fruit extract, haematococcus
pluvialis (astaxanthin) powder*, simmondsia chinensis
(jojoba) seed oil*, aloe barbadensis leaf juice*, camellia
sinensis leaf (green tea) extract, citrus aurantium amara
(bitter orange) flower distillate*, isopropyl jojobate, jojoba
alcohol, jojoba esters, xanthan gum, polyglyceryl-6 behenate,
lactic acid, acacia senegal gum, dipotassium glycyrrhizate,
allantoin, phenethyl alcohol, ethylhexylglycerin, sodium
phytate, glycerin, leuconostoc/radish root ferment filtrate,
tocopherol.
Other Information
• Protect the product in this container from
excessive heat and direct sun.
Questions Or Comments
Call 1-888-4160870 M-F 9am-5pm EST
* Please review the disclaimer below.
