Lip Screen Broad Spectrum Spf 40

Lip Screen Broad Spectrum Spf 40
SPL v6
SPL
SPL Set ID a3e5819a-5132-9760-e053-2a95a90a058b
Route
TOPICAL
Published
Effective Date 2020-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octocrylene (10 g) Octisalate (5 g) Homosalate
Inactive Ingredients
Ethyl Acetate Caprylyl Glycol Citric Acid Monohydrate Polyester-7 Tocopherol Dimethylhydroxy Furanone 2-hexenal, (2e)- Diethylhexyl Syringylidenemalonate Laminaria Ochroleuca Agathosma Betulina Leaf Oil Vanillin 2-methylbutyric Acid Sesame Oil .gamma.-undecalactone Diisostearyl Malate Alkyl (c12-15) Benzoate Medium-chain Triglycerides Butyloctyl Salicylate Hydrogenated Polybutene (1300 Mw) Stevioside Vitis Vinifera Seed Shea Butter Coconut Oil Isopropyl Palmitate Neopentyl Glycol Diheptanoate Soybean Oil Benzaldehyde

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-04-22
Description

Avobenzone 3% Sunscreen Homosalate 5% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen

Medication Information

Warnings and Precautions

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

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

Apply generously and evenly 15 minutes before sun exposure

Use a water-resistant sunscreen if swimming or sweating

Reapply 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 your time in the sun, especially from 10

a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses •

Children under 6 months of age: ask a doctor.

Description

Avobenzone 3% Sunscreen Homosalate 5% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen

Section 50565-1

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

Section 51727-6

Inactive Ingredients

Hydrogenated Polyisobutene, Diisostearyl Malate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Polyurethane-79, Polyester-7, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Isopropyl Palmitate , Sesamum Inidicum (Sesame) Seed Oil, Neopentyl Glycol Diheptanoate, Diethylhexyl Syringlidenemalonate, Caprylyl Glycol, Glycine Soja (Soybean) Oil, Tocopherol, 2-Methylbutyric Acid, Barosma Betulina Leaf Oil, Benzaldehyde, Dimethylhydroxy Furanone, Trans-2-Hexenal, Helianthus Annuus (Sunflower) Seed Oil, Ethyl Acetate, Stevioside, Gamma-Undecalactone, Vanillin, Vitis Vinifera (Grape) Seed Extract, Laminaria Ochroleuca Extract, Citric Acid

Section 51945-4

Lip Screen

SPF 40

Broad Spectrum SPF 40

0.34 fl. oz. / 10 ml.

Section 55105-1

Uses

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.

Section 55106-9

Avobenzone 3% Sunscreen

Homosalate 5% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

Apply generously and evenly 15 minutes before sun exposure

Use a water-resistant sunscreen if swimming or sweating

Reapply 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 your time in the sun, especially from 10

a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses •

Children under 6 months of age: ask a doctor.

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients

Hydrogenated Polyisobutene, Diisostearyl Malate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Polyurethane-79, Polyester-7, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Isopropyl Palmitate , Sesamum Inidicum (Sesame) Seed Oil, Neopentyl Glycol Diheptanoate, Diethylhexyl Syringlidenemalonate, Caprylyl Glycol, Glycine Soja (Soybean) Oil, Tocopherol, 2-Methylbutyric Acid, Barosma Betulina Leaf Oil, Benzaldehyde, Dimethylhydroxy Furanone, Trans-2-Hexenal, Helianthus Annuus (Sunflower) Seed Oil, Ethyl Acetate, Stevioside, Gamma-Undecalactone, Vanillin, Vitis Vinifera (Grape) Seed Extract, Laminaria Ochroleuca Extract, Citric Acid

Section 51945-4 (51945-4)

Lip Screen

SPF 40

Broad Spectrum SPF 40

0.34 fl. oz. / 10 ml.

Section 55105-1 (55105-1)

Uses

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.

Section 55106-9 (55106-9)

Avobenzone 3% Sunscreen

Homosalate 5% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:02.183830 · Updated: 2026-03-14T23:01:14.422395