Otc - Active Ingredient
Active Ingredients
Avobenzone 2.5%Octinoxate 7.5%
Octocrylene 5.0%
Golfersskin Sunscreen Lip Balm
FDA Label NDC 75916-0664
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 Golfersskin Sunscreen Lip Balm (NDC 75916-0664). 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, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Octinoxate 7.5%
Octocrylene 5.0%
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
Uses
Helps prevent sunburn
Higher SPF gives more sunburn protection
Provides high protection against sunburn
Retains 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
Keep out of reach of children.
Dosage & Administration
DirectionsApply generously 15 mins before sun exposure and as neededChildren under 6 months of age; ask a doctorReapply as needed or after towel drying, swimming or sweating.
Inactive Ingredient
Inactive Ingredients
Aloe vera, Beeswax, Capryllic/Capric Triglyceride, Castor Oil, Jojoba Oil, Lanolin, Tocopheryl Acetate, Vanilla lip
Description
Golfers Skin SPF 30+ Sunscreen Lip Balm moisturizes lips with Vitamin E and Aloe Vera
To report a serious adverse event, contact 1-800-332-1088
Expires:
Lot Number:
www.golfersskin.co
DIST. BY Quiver Dist, Bend Oregon, USA 97701
AS/ANZ STANDARD 2604-1998
Tested on Golfers - Not Animals
Net Wt. .3oz (8.5g)
Package Label.Principal Display Panel
SPF 30+
very water / sweat resistant
broad spectrum
UVA/UVB protection
Proven in extreme New Zealand conditions
Golfers Skin sunscreen lip balm
Net Wt. .30 oz (8.5g)
contains no nanoparticles - aminobenzoic acid (PABA)-free
Golfers Skin Lip Balm (Golferskin Tube)
Golfer Skin Sunscreen (Golferskin Box)
* Please review the disclaimer below.
