Otc - Active Ingredient
Active Ingredients
Octinoxate 7.5%
Titanium Dioxide 2.35%
Zinc Oxide 4.2%
Snowskin Sunscreen Zinc
FDA Label NDC 75916-0634
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skin Alive, Ltd. for the product Snowskin Sunscreen Zinc (NDC 75916-0634). 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, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, inactive ingredient, 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
Higher SPF gives more sunburn protection
Provides high protection against sunburn
Regains SPF after 80 minutes of sweating.
Warnings
Warnings
For external use only
UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen.
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 irritation occurs or rash develops and lasts.
Otc - Keep Out Of Reach Of Children
Directions
apply generously 15mins before sun exposure and as needed
Children under 6 months of age: ask a doctor.
Reapply as needed or after towel drying, swimming or sweating.
Inactive Ingredient
Inactive Ingredients
Alumina, Aluminum Stearate, Avocado Oil, Beeswax, C12-15 Alkyl Bezoate, Candellia Wax, Capryllic/capric Triglyceride, Cydomethicone, Fragrance, Hydrogenerated Castor Wax, Isohexadecane, Isopropyl Myristate, Isosteric Acid, Lanolin Anhydrous, Microwax, Polyhidroxystearic Acid, Polyhydroxystearic Acid, PPG-3 Benzyl Ether Myristate, Triethylhexanoin.
Description
Snowskin SPF 30+ Sunscreen Zinc gives great protection especially in the snow. Apply liberally to face, nose and lips.
To report a serious adverse event, contact 1-800-332-1088
Expires:
Lot Number:
ww.snowskin.co
DIST. BY Quiver Dist, Bend Oregon, USA 97701
Tested on Snowboarders - Not animals
AS/ANZ STANDARD 2604-1998
Net Wt. 0.30ox (8.5g)
Package Label.Principal Display Panel
SPF 30+
very water / sweat resistant
broad spectrum
UVA/UVB protection
Proven in extreme new zealand conditions
SnowSkin sunscreen Zinc
hands free
Net Wt. 0.30oz (8.5g)
contains no nanoparticles-aminobenzoic acid (PABA) free
Snowskin Sunscreen Zinc (Snowskinzinc)
Snowskin Sunscreen Zinc2 (Snowskinzinc Outer)
* Please review the disclaimer below.
