Play Lip Balm With Acai Broad Spectrum Sunscreen Spf 30

Play Lip Balm With Acai Broad Spectrum Sunscreen Spf 30
SPL v5
SPL
SPL Set ID 9f5b54c7-a424-6917-e053-2a95a90ac627
Route
TOPICAL
Published
Effective Date 2020-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Avobenzone (3 g) Octocrylene (5 g) Octisalate
Inactive Ingredients
Ethyl Acetate Sheanut Butyloctyl Salicylate Glyceryl Monostearate Safflower Oil Sesame Oil .gamma.-undecalactone 2-methylbutyric Acid Acai Agathosma Betulina Leaf Oil Vanillin Hydrogenated Polybutene (1300 Mw) Ceresin Cetyl Alcohol Polyglyceryl-10 Decaoleate Sunflower Oil Stevioside Benzaldehyde Dimethylhydroxy Furanone 2-hexenal, (2e)- Tocopherol Soybean Oil Trihydroxystearin Polyisobutylene (1300 Mw) Diethylhexyl 2,6-naphthalate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-27

Description

Active Ingredients Purpose Avobenozone 3% Sunscreen Homosalate 10% 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

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating

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

Active Ingredients Purpose Avobenozone 3% Sunscreen Homosalate 10% 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, Polyisobutene, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C18-38 Alkyl Hydroxystearoyl Stearate, Ozokerite, Cetyl Alcohol, Diethylhexyl 2,6-Naphthalate, Glyceryl Stearate, Polyglyceryl-10 Decaoleate, Carthamus Tinctorius (Safflower) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Trihydroxystearin, Helianthus Annuus (Sunflower) Seed Oil, Stevioside, 2-Methylbutyric Acid, Barosma Betulina Leaf Oil, Benzaldehyde, Dimethylhydroxy Furanone, Trans-2-Hexenal, Tocopherol, Glycine Soja (Soybean) Oil, Euterpe Oleracea Fruit Extract, Ethyl Acetate, Gamma-Undecalactone, Vanilin

Section 51945-4

Supergoop!

PLAY

SPF 30

LIP BALM with Acai

Broad Spectrum Sunscreen SPF 30

0.5 fl. oz./ 15 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

Active Ingredients Purpose

Avobenozone 3% Sunscreen

Homosalate 10% 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

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating

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, Polyisobutene, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C18-38 Alkyl Hydroxystearoyl Stearate, Ozokerite, Cetyl Alcohol, Diethylhexyl 2,6-Naphthalate, Glyceryl Stearate, Polyglyceryl-10 Decaoleate, Carthamus Tinctorius (Safflower) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Trihydroxystearin, Helianthus Annuus (Sunflower) Seed Oil, Stevioside, 2-Methylbutyric Acid, Barosma Betulina Leaf Oil, Benzaldehyde, Dimethylhydroxy Furanone, Trans-2-Hexenal, Tocopherol, Glycine Soja (Soybean) Oil, Euterpe Oleracea Fruit Extract, Ethyl Acetate, Gamma-Undecalactone, Vanilin

Section 51945-4 (51945-4)

Supergoop!

PLAY

SPF 30

LIP BALM with Acai

Broad Spectrum Sunscreen SPF 30

0.5 fl. oz./ 15 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)

Active Ingredients Purpose

Avobenozone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)