SPL v4
SPL
SPL Set ID 7885f941-94f0-c936-e053-2991aa0acba5
Route
TOPICAL
Published
Effective Date 2018-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-10-19 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.

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.

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

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(R)

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

lightweight & oil-free formula

with green tea extract

Recommended as an

effective broad spectrum

sunscreen

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.

May stain some fabrics.


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.

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

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(R)

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

lightweight & oil-free formula

with green tea extract

Recommended as an

effective broad spectrum

sunscreen

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 (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.

May stain some fabrics.


Advanced Ingredient Data


Raw Label Data

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