SPL v2
SPL
SPL Set ID 17670182-2b2e-ce40-e063-6294a90a2913
Route
TOPICAL
Published
Effective Date 2023-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (6 g) Homosalate (2.7 g) Avobenzone
Inactive Ingredients
Isododecane Caprylyl Glycol Dimethicone Diisopropyl Adipate Alcohol Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-01-05 Until 2026-10-31

Description

Avobenzone 2.7%, Homosalate 6.0%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 6.0%, Octocrylene 6.0%

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

Warnings

For external use only

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics and surfaces.

Directions

Hold container 4 to 6 inches from the skin to apply. Don’t spray directly into face. Apply on hand then apply to face. Spray evenly and liberally on your skin. Apply 15 minutes before sun exposure. Reapply throughout the day • at least every 2 hours, • after 80 minutes of swimming or sweating • immediately after towel drying • 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 this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%, Homosalate 6.0%, Octocrylene 6.0%

Inactive Ingredients

Alcohol Denat., Isododecane, Diisopropyl Adipate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Camellia Sinensis Leaf Extract.

Questions Or Comments?

Call 1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC®

OIL-FREE SUNSCREEN MIST

SKIN DEFENSE

PROTECTS AGAINST UVA SKIN AGING

GREEN TEA EXTRACT

30

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

3.4 FL. OZ (100 mL)

When Using This Product

Keep away from face to avoid breathing it • Keep out of eyes. Rinse with 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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.


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 skin aging caused by the sun

Purpose

Sunscreen

Warnings

For external use only

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics and surfaces.

Directions

Hold container 4 to 6 inches from the skin to apply. Don’t spray directly into face. Apply on hand then apply to face. Spray evenly and liberally on your skin. Apply 15 minutes before sun exposure. Reapply throughout the day • at least every 2 hours, • after 80 minutes of swimming or sweating • immediately after towel drying • 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 this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%, Homosalate 6.0%, Octocrylene 6.0%

Inactive Ingredients

Alcohol Denat., Isododecane, Diisopropyl Adipate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Camellia Sinensis Leaf Extract.

Questions Or Comments? (Questions or Comments?)

Call 1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC®

OIL-FREE SUNSCREEN MIST

SKIN DEFENSE

PROTECTS AGAINST UVA SKIN AGING

GREEN TEA EXTRACT

30

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

3.4 FL. OZ (100 mL)

When Using This Product (When using this product)

Keep away from face to avoid breathing it • Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)