Otc - Active Ingredient
ACTIVE INGREDIENTS: Zinc Oxide – 20.6%
Sr Active Sheer Zinc Face Stick Spf 50 Stick
FDA Label NDC 83694-021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skinresource.md, L.l.c. for the product Sr Active Sheer Zinc Face Stick Spf 50 (NDC 83694-021). 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, dosage & administration, warnings, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, sr active face stick, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
• 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: Ask a doctor.
Warnings
Warnings (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 a rash occurs.
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Inactive Ingredients:
Bisabolol*
Butyloctyl Salicylate
Butyrospermum Parkii (Shea) Butter*
Cocos Nucifera (Coconut) Oil*
Copernicia Cerifera (Carnauba) Wax
Euphorbia Cerifera (Candelilla) Wax
Helianthus Annuus (Sunflower) Seed Oil
Olea Europaea (Olive) Fruit Oil
Oryzanol
Theobroma Cacao (Cocoa) Seed Butter
Tocopherol
*Certified Organic Ingredients
Otc - Purpose
Zinc Oxide - 20.6% Sunscreen
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.
Indications & Usage
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.
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.
Wearlong-sleved shirts, pants, hats, and sunglasses.
• 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.
Sr Active Face Stick
Package Label
* Please review the disclaimer below.
