GOLFERSSKIN SUNSCREEN LIP BALM- avobenzone, octinoxate, octocrylene stick

GolfersSkin Sunscreen Lip Balm by

Drug Labeling and Warnings

GolfersSkin Sunscreen Lip Balm by is a Otc medication manufactured, distributed, or labeled by Skin Alive, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone 2.5%
Octinoxate 7.5%
Octocrylene 5.0%

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.

WHEN USING

When using this product

Keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor

if irritation occurs or rash develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions
Apply generously 15 mins 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

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)

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOLFERSSKIN SUNSCREEN LIP BALM 
avobenzone, octinoxate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75916-0664
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JOJOBA OIL (UNII: 724GKU717M)
LANOLIN (UNII: 7EV65EAW6H)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75916-0664-8	1 in 1 BOX
1		8.5 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/19/2011

Labeler - Skin Alive, Ltd. (593384746)