SPL v4
SPL
SPL Set ID 837332ab-caf4-6006-e053-2991aa0a4df9
Route
TOPICAL
Published
Effective Date 2019-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (6 g) Avobenzone (2.7 g) Octocrylene
Inactive Ingredients
Caprylyl Glycol Dimethicone Camellia Sinensis Whole Alcohol Isododecane Diisopropyl Adipate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-03-06 Until 2025-10-31

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.

Section 51945-4

HAWAIIAN

Tropic

AntiOxidant+

REFRESH SUNSCREEN MIST

Helps prevent skin damage

& skin aging from the sun

30

SPF 30 BROAD SPECTRUM SUNSCREEN SPRAY

UVA & UVB PROTECTION

Good for FACE and BODY

with green tea extract.

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.

Directions

Hold container 4 to 8 inches from the skin to apply. Don't spray directly into face. Apply on hand then apply to face. Spray evenly and liberatly 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

Active Ingredient

Avobenzone 2.7%, Homosalate 6.0%, Octocrylene 6.0%

Other Information

Protect this product from excessive heat and direct sun.

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

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.


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.

Section 51945-4 (51945-4)

HAWAIIAN

Tropic

AntiOxidant+

REFRESH SUNSCREEN MIST

Helps prevent skin damage

& skin aging from the sun

30

SPF 30 BROAD SPECTRUM SUNSCREEN SPRAY

UVA & UVB PROTECTION

Good for FACE and BODY

with green tea extract.

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 (May stain)

some fabrics.

Directions

Hold container 4 to 8 inches from the skin to apply. Don't spray directly into face. Apply on hand then apply to face. Spray evenly and liberatly 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

Active Ingredient

Avobenzone 2.7%, Homosalate 6.0%, Octocrylene 6.0%

Other Information

Protect this product from excessive heat and direct sun.

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

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 (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)