Drug Facts
Active ingredient
Zinc Oxide 14.96%
Beautycounter Countersun Daily Sheer Defense For Face
FDA Label NDC 21839-615
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gordon Laboratories, Inc. for the product Beautycounter Countersun Daily Sheer Defense For Face (NDC 21839-615). 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 drug facts, 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
Purpose
Sunscreen
Indications & Usage
Uses * Helps prevent sunburn.
* If used as directed with other sun protection ( see Directions), decreases the risk of skin cancer and early skin aging caused by sun.
Warnings
Warnings
For external use only.
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Do not use on damaged or broken skin.
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When using this product, keep out of
eyes. Rinse with water to remove.
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Stop use and ask a doctor if rash occurs.
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Keep out of reach of children.
If swallowed, get medical help or contact
a Poison Control Center right away.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product, keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions *Apply liberally and
evenly 15 minutes before sun exposure.
* Reapply at least every 2 hours.
* Use a water-resistant sunscreen if
swimming or sweating.
* Children under 6 months: 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 usa 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
Other information * Protect the
product in this container from excessive
heat and direct sun.
Inactive Ingredients
Inactive ingredients
Water, Coco-Caprylate, Caprylic/Capric Triglyceride, Squalane, Glycerin, Pentylene Glycol, Cetearyl Alcohol, Coconut Alkanes, Arachidyl Alcohol, Coco-Glucoside, Phenoxyethanol, Behenyl Alcohol, Tocopherol, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Xanthan Gum, Arachidyl Glucoside, Phytic Acid, Isostearic Acid, Lecithin, Cichorium Intybus (Chicory) Root Extract, Helianthus Annuus (Sunflower) Seed Oil*, Coco-Caprylate/Caprate, Ethylhexylglycerin, Sodium Hyaluronate.
*Organic
Questions
Questions? (888) 701-9899
Serious side effects associated with use
of this product may be reported to this number.
Package Label
* Please review the disclaimer below.
