OKEEFFES LIP REPAIR- avobenzone, dimethicone, octinoxate, octocrylene ointment
The Gorilla Glue Company/O'Keeffe's Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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O'KEEFFE'S LIP REPAIR SPF 35 TUBE

Drug Facts

Active ingredients

Avobenzone 2.5%

Dimethicone 17.5%

Octinoxate 6%

Octocrylene 2%

Purposes

Sunscreen

Lip Protectant

Sunscreen

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

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

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

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

Other information Protect this product from excessive heat and direct sun

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 or comments? 1-800-275-2718

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

2101 E. Kemper Rd. Cincinnati, OH 45241

Made in USA with Domestic and Imported Materials

O'KEEFFE'S LIP REPAIR

SPF 35

Lip Protectant

Sunscreen

for extremely dry, cracked lips

SOOTHING ALOEBOOST

Broad Spectrum SPF 35

Water Resistant (80 minutes)

GUARANTEED RELIEF

Net Wt. 0.30 oz. (8.5 g)

71564-002 Lip Repair SPF 35 01-2022

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71564-002-85	1 in 1 BLISTER PACK	03/22/2018	11/30/2021
1		8.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/22/2018	11/30/2021

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

Revised: 3/2023

Document Id: f658fc97-550e-5b11-e053-2995a90a7362

Set id: 69bf3b9d-a9dd-d000-e053-2a91aa0a306a

Version: 4

Effective Time: 20230307

The Gorilla Glue Company/O'Keeffe's Company