O'keeffe's Lip Repair Spf 35 Stick

O'keeffe's Lip Repair Spf 35 Stick
SPL v5
SPL
SPL Set ID 6805b3e9-77cb-bfee-e053-2991aa0a8d98
Route
TOPICAL
Published
Effective Date 2022-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.5 g) Dimethicone (17.5 g) Octinoxate (6 g) Octocrylene (2 g)
Inactive Ingredients
Shea Butter Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Corn Oil Hydrogenated Polybutene (1300 Mw) Saccharin Aloe Vera Leaf Hydrogenated Poly(c6-14 Olefin; 2 Cst) Lime Oil Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Yellow Wax Petrolatum Phenyl Trimethicone Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s) Almond Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-22
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and 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
Dosage and 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
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information Protect this product from excessive heat and direct sun

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients Beeswax, Petrolatum, Hydrogenated Poly (C6-14 Olefin), Phenyl Trimethicone, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Butyrospermum Parkii (Shea) Butter, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Flavor, Polysilicone-11, Hydrogenated Polyisobutane, 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

Section 51945-4

O'KEEFFE'S LIP REPAIR

SPF 35

Lip Protectant

Sunscreen

for extremely dry, cracked lips

SOOTHING ALOE BOOST

Broad Spectrum SPF 35

Water Resistant (80 minutes)

GUARANTEED RELIEF

Net Wt. 0.15 oz. (4.2 g)

Section 53413-1

Questions or comments? 1-800-275-2718

Section 55105-1

Purposes

Sunscreen

Lip Protectant

Sunscreen

Sunscreen

Section 55106-9

Active ingredients

Avobenzone 2.5%

Dimethicone 17.5%

Octinoxate 6%

Octocrylene 2%

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information Protect this product from excessive heat and direct sun

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients Beeswax, Petrolatum, Hydrogenated Poly (C6-14 Olefin), Phenyl Trimethicone, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Butyrospermum Parkii (Shea) Butter, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Flavor, Polysilicone-11, Hydrogenated Polyisobutane, 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

Section 51945-4 (51945-4)

O'KEEFFE'S LIP REPAIR

SPF 35

Lip Protectant

Sunscreen

for extremely dry, cracked lips

SOOTHING ALOE BOOST

Broad Spectrum SPF 35

Water Resistant (80 minutes)

GUARANTEED RELIEF

Net Wt. 0.15 oz. (4.2 g)

Section 53413-1 (53413-1)

Questions or comments? 1-800-275-2718

Section 55105-1 (55105-1)

Purposes

Sunscreen

Lip Protectant

Sunscreen

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Avobenzone 2.5%

Dimethicone 17.5%

Octinoxate 6%

Octocrylene 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:14.713281 · Updated: 2026-03-14T23:12:25.780176