Active Ingredients
Active Ingredients
Octinoxate 7.5%
Oxybenzone 3.45%
Titanium Dioxide 1%
Zinc Oxide 1.95%
Surfers Skin Sunscreen
FDA Label NDC 75916-4019
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 Surfers Skin Sunscreen (NDC 75916-4019). 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 ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
Sunscreen
Uses
Helps prevent Sunburn
Higher SPF gives more sunburn protection
Provides high protection against sunburn
Retains SPF after 80 minutes of swimming
Warnings
Warnings
For external use only
UV exposure from the sun increases the risk of skin cancer, premature 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.
When Using This Product
When using this product
Keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor If
Irritation occurs or rash develops and lasts
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
Apply generously 15 min 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 Ingredients
Aloe Vera Gel, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cyclomethicone, Deionised Water, Fragrance, Glyceryl Monostearate, Phenoxyethanol, Polysorbate 60, PVP?ejcosene, Retinol Palminate, Sorbitan Monostearate, Tocopherol Acetate, UMF 18 Manuka Honey
Description
Surfersskin SPF 30+ Sunscreen, VERY WATER/SWEAT RESISTANT, BROAD SPECTRUM, UVA/UVB PROTECTION. keep your "Skin Alive" with this non greasy sweat resistant formula that won't runinto your eyes and give you up to 80 mins protection in the water.
Made in NZ
Skin alive
Expires:
Lot Number
www.surfersskin.co
DIST. BY: Quiver Dist., Bend Oregon, USA 97701
AS/ANZ STANDARD 2604-1998
4.2 fl oz (125ml)
To report a serious adverse event, contact 1-800-332-1088
Package Label.Principal Display Panel
spf 30+
very water/sweat resistant
broad spectrum
UVA/UVB Protection
Surfersskin Sunscreen
Proven in Extreme New Zealand conditions
4.2 fl oz (125ml)
manuka honey UMF 18
CONTAINS NO NANOPARTICLES - AMINOBENZOIC ACID (PABA)-FREE
Surfersskin Sunscreen (Surferssunscreen1)
Surfersskin Sunscreen (Surferssunscreen Outer)
* Please review the disclaimer below.
