SPL v2
SPL
SPL Set ID 228055ec-ff59-4412-e063-6394a90abe14
Route
TOPICAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9 g) Avobenzone (2.7 g) Homosalate (5 g) Octisalate (4.5 g)
Inactive Ingredients
Candelilla Wax Cetyl Alcohol Sunflower Oil Synthetic Beeswax Shea Butter Ceresin Water Stevioside Petrolatum Cocoa Butter Yellow Wax Polyglyceryl-3 Beeswax Tocopherol Hydrogenated Coconut Oil Hydrogenated Soybean Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Avobenzone 2.7%, Homosalate 5.0%, Octisalate 4.5%, Octocrylene 9.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 5.0%, Octisalate 4.5%, Octocrylene 9.0%

Uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

May stain some fabrics.

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

Do Not Use

on damaged or broken skin.

Other Information

•Protect the product in this container from excessive heat and direct sun

Active Ingredients:

Avobenzone 2.7%, Homosalate 5.0%, Octisalate 4.5%, Octocrylene 9.0%

Inactive Ingredients:

Petrolatum, Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Ozokerite, Polyglyceryl-3 Beeswax, Polydipentene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil, Hydrogenated Soybean Oil, Flavor, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Stevioside, Tocopherol, Water.

Questions Or Comments?

Call 1-800-NO UV Ray

Principal Display Panel

NEW

HAWAIIAN TROPIC

SUNSCREEN

LIP BALM

12 HR MOISTURIZATION

ENRICHED WITH

VITAMIN E &

SHEA BUTTER

WATER

RESISTANT

(80 MINUTES)

30

BROAD SPECTRUM

SPF 30 UVA/UVB

NET WT. 0.35 OZ. (9.9 g)

HAWAIIAN TROPIC

SUNSCREEN

LIP BALM

12 HR MOISTURIZATION

ENRICHED WITH

VITAMIN E &

SHEA BUTTER

WATER RESISTANT (80 MINUTES)

30

ISLAND COCONUT

BROAD SPECTRUM SPF 30 UVA/UVB

NET WT. 0.35 OZ. (9.9 g)

When Using This Product

keep out of eyes. Rinse with warm water to remove.

Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun.

Purpose

Sunscreen

Warnings

For external use only.

May stain some fabrics.

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

Do Not Use (Do not use)

on damaged or broken skin.

Other Information

•Protect the product in this container from excessive heat and direct sun

Active Ingredients:

Avobenzone 2.7%, Homosalate 5.0%, Octisalate 4.5%, Octocrylene 9.0%

Inactive Ingredients:

Petrolatum, Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Ozokerite, Polyglyceryl-3 Beeswax, Polydipentene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil, Hydrogenated Soybean Oil, Flavor, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Stevioside, Tocopherol, Water.

Questions Or Comments? (Questions or comments?)

Call 1-800-NO UV Ray

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW

HAWAIIAN TROPIC

SUNSCREEN

LIP BALM

12 HR MOISTURIZATION

ENRICHED WITH

VITAMIN E &

SHEA BUTTER

WATER

RESISTANT

(80 MINUTES)

30

BROAD SPECTRUM

SPF 30 UVA/UVB

NET WT. 0.35 OZ. (9.9 g)

HAWAIIAN TROPIC

SUNSCREEN

LIP BALM

12 HR MOISTURIZATION

ENRICHED WITH

VITAMIN E &

SHEA BUTTER

WATER RESISTANT (80 MINUTES)

30

ISLAND COCONUT

BROAD SPECTRUM SPF 30 UVA/UVB

NET WT. 0.35 OZ. (9.9 g)

When Using This Product (When using this product)

keep out of eyes. Rinse with warm water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.


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