SPL v1
SPL
SPL Set ID 302982a3-e3f9-ef46-e063-6394a90abaf8
Route
TOPICAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4.5 g) Homosalate (9 g) Avobenzone (2.7 g) Octocrylene
Inactive Ingredients
Caprylyl Glycol Psidium Guajava Fruit Ethylhexyl Palmitate Cetyl Alcohol Theobroma Cacao (cocoa) Seed Butter Carica Papaya (papaya) Fruit Dimethicone Silica Mangifera Indica (mango) Fruit Diisopropyl Adipate Peg-8 Passiflora Incarnata Fruit Ceresin Plumeria Rubra Flower Caprylic/capric Triglyceride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

Inactive Ingredients:

Ozokerite, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone, PEG‐8, Caprylyl Glycol, Silica, Fragrance, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract

Questions Or Comments?

Call 1-800-NO UV Ray

Principal Display Panel

HAWAIIAN TROPIC

SUNSCREEN STICK

WEIGHTLESS

HYDRATION

12 HOUR MOISTURIZATION

60+

BROAD SPECTRUM SPF 60+ UVA/UVB

SWEAT | WATER RESISTANT (80 MINUTES)

NET WT. 0.5 OZ (14.2 g)

NEW

HAWAIIAN

TROPIC

SUNSCREEN STICK

WEIGHTLESS

HYDRATION

12 HOUR MOISTURIZATION

WON'T CLOG

PORES

DERM TESTED

BLENDS ACROSS

SKIN TONES

VEGAN

60+

BROAD SPECTRUM

SPF 60+ UVA/UVB

SWEAT | WATER

RESISTANT

(80 MINUTES)

NET WT. 0.5 OZ (14.2 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 9.0%, Octisalate 4.5%, Octocrylene 9.0%

Inactive Ingredients:

Ozokerite, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone, PEG‐8, Caprylyl Glycol, Silica, Fragrance, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract

Questions Or Comments? (Questions or comments?)

Call 1-800-NO UV Ray

Principal Display Panel

HAWAIIAN TROPIC

SUNSCREEN STICK

WEIGHTLESS

HYDRATION

12 HOUR MOISTURIZATION

60+

BROAD SPECTRUM SPF 60+ UVA/UVB

SWEAT | WATER RESISTANT (80 MINUTES)

NET WT. 0.5 OZ (14.2 g)

NEW

HAWAIIAN

TROPIC

SUNSCREEN STICK

WEIGHTLESS

HYDRATION

12 HOUR MOISTURIZATION

WON'T CLOG

PORES

DERM TESTED

BLENDS ACROSS

SKIN TONES

VEGAN

60+

BROAD SPECTRUM

SPF 60+ UVA/UVB

SWEAT | WATER

RESISTANT

(80 MINUTES)

NET WT. 0.5 OZ (14.2 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 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.


Advanced Ingredient Data


Raw Label Data

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