Otc - Active Ingredient
Secondary (Secondary)
Squalane Zinc Sheer Mineral Sunscreen
FDA Label NDC 73517-125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amyris, Inc for the product Squalane Zinc Sheer Mineral Sunscreen (NDC 73517-125). 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, purpose, uses warnings directions, inactive ingredients:, other information, 50 ml ndc 73517-125-01, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Zinc Oxide 14% Sunscreen
Uses Warnings Directions
Helps prevent sunburn
if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early signs of 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 product is swallwed get medical help or contact Poison Control Center right away
Directions
apply generously 15 minutes before sun exposure. reapply at least every 2 hours
Sun Protection Measures
Spendign 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 value of SPF 15 or higher and other sun protections measures including: limit time in the sun, especially from 10 am - 2pm
wear long-sleeved shirts, pants, hats, and sunglasses
use a water resistant sunscreen if swimming or sweating
children under 6 months of age ask a doctor.
Inactive Ingredients:
Inactive Ingredients: Water, Caprylic/Capric Triglyceride, Squalane, Glycerin, Cetearyl Alcohol, Methyl Dihydroabietate, Sorbitan Olivate, Coco-Glucoside, Cetyl Palmitate, Polyglyceryl-3 Polyricinoleate, Caprylyl/Capryl Glucoside, Nymphaea Alba Flower Extract, Acacia Senegal Gum, Ethyl Ferulate, Xanthan Gum, Sodium Gluconate, Lecithin, Sodium Palmitoyl Proline, Polyhydroxystearic Acid, Ethylhexylglycerin, Phenoxyethanol, Isostearic Acid.
Other Information
protect this product from excessive heat and direct sun
50 Ml Ndc 73517-125-01
Secondary (Secondary)
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