OKeeffes Lip Repair

Manufacturer
The Gorilla Glue Company/O'Keeffe's Company
Effective date
2022-01-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:11:31

Label at a glance#

ProductOKeeffes Lip Repair
Active ingredientAVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE
Label structure15 sections

Storage and handling

Other information Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 2.5%

Dimethicone 17.5%

Octinoxate 6%

Octocrylene 2%

OTC - PURPOSE SECTION

Purposes

Sunscreen

Lip Protectant

Sunscreen

Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

©2019 Distributed by: O'Keeffe's Company

2101 E. Kemper Rd. Cincinnati, OH 45241

Made in USA with Domestic and Imported Materials

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 01-202271564-002 Lip Repair SPF 35 01-2022

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71564-00271564-002-85

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f658fc97-550e-5b11-e053-2995a90a736269bf3b9d-a9dd-d000-e053-2a91aa0a306a2023-03-07WarningsExact identifier
spl set id: 69bf3b9d-a9dd-d000-e053-2a91aa0a306a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.