OKEEFFES LIP REPAIR- avobenzone, dimethicone, octinoxate, octocrylene ointment

OKeeffes Lip Repair by

Drug Labeling and Warnings

OKeeffes Lip Repair by is a Otc medication manufactured, distributed, or labeled by The Gorilla Glue Company/O'Keeffe's Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Avobenzone 2.5%

Dimethicone 17.5%

Octinoxate 6%

Octocrylene 2%

PURPOSE

Purposes

Sunscreen

Lip Protectant

Sunscreen

Sunscreen

INDICATIONS & USAGE

Uses

• temporarily protects and helps relieve chapped or cracked lips
• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• reapply: after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures: Spending 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 SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor

STORAGE AND HANDLING

Other information Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients Beeswax, Petrolatum, Phenyl Trimethicone, Hydrogenated Poly (C6-14 Olefin), Butyrospermum Parkii (Shea) Butter, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Hydrogenated Polyisobutane, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polysilicone-11, Flavor, Hydrogenated Vegetable Oil, Ethylene/Propylene/Styrene Copolymer, Sodium Saccharin, Citrus Aurantifolia (Lime) Peel Oil, Aloe Barbadensis Leaf Extract, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

QUESTIONS

Questions or comments? 1-800-275-2718

SPL UNCLASSIFIED SECTION

Contains decolorized Aloe Barbadensis Leaf Extract

Repairs extremely dry, cracked lips

100% Money Back Guarantee: If you are not fully satisfied with the performance of this product, we will refund 100% of the purchase price. For a prompt refund, simply return the unused portion of this product and your receipt to: O'Keeffe's Company.

LIP REPRESENTATIVE PHOTOS: Two week usage period. Lip balm was applied according to package directions. Results may vary.

www.OKeeffesCompany.com

©2017 Distributed by: O'Keeffe's Company

2101 E. Kemper Rd. Cincinnati, OH 45241

Made in USA with Domestic and Imported Materials

PRINCIPAL DISPLAY PANEL

NEW

SOOTHING ALOEBOOST

GUARANTEED HARDWORKING SKINCARE

O'Keeffe's Lip Repair®

SPF 35

Lip Protectant/Sunscreen

GUARANTEED RELIEF FOR EXTREMELY DRY, CRACKED LIPS

ALL DAY Moisture

Broad Spectrum SPF 35

Water Resistant (80 minutes)

Net Wt. 0.30 oz. (8.5 g)

INGREDIENTS AND APPEARANCE

OKEEFFES LIP REPAIR 
avobenzone, dimethicone, octinoxate, octocrylene ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71564-002
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
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	17.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
LIME OIL (UNII: UZH29XGA8G)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71564-002-85	1 in 1 BLISTER PACK	03/22/2018
1		8.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/22/2018

Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)