SPL v1
SPL
SPL Set ID 3cf42e31-4e11-9b6d-e063-6294a90aa741
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.7 g) Homosalate (6 g) Octisalate (4.5 g) Octocrylene
Inactive Ingredients
Water Silicon Dioxide Chlorphenesin Mica Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Hibiscus Sabdariffa Flower Papaya Glycerin Aloe Vera Leaf Mango Plumeria Rubra Flower Passiflora Incarnata Fruit Propylene Glycol Caprylyl Glycol Phenoxyethanol Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-10-01 Until 2026-10-31
Description

Avobenzone 2.7%, Homosalate 6.0%, Octisalate 4.5%, Octocrylene 4.5%

Purpose

Sunscreen Agent

Medication Information

Purpose

Sunscreen Agent

Description

Avobenzone 2.7%, Homosalate 6.0%, Octisalate 4.5%, Octocrylene 4.5%

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.

May stain some fabrics and surfaces.

Directions

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two 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 this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%, Homosalate 6.0%, Octisalate 4.5%,

Octocrylene 4.5%

Inactive Ingredients

Water, Silica, Propylene Glycol, Cetyl Dimethicone, Phenoxyethanol, Mica, Sodium Polyacrylate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Fragrance, Chlorphenesin, Glycerin, Disodium EDTA, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Hibiscus Sabdariffa Flower Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Titanium Dioxide.

Stop and Ask A Doctor

if rash occurs.

Questions Or Comments?

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

Principal Display Panel

HAWAIIAN TROPIC

OIL-FREE SUNSCREEN

SHEER TOUCH

FACE SERUM

LEAVES SKIN RADIANT

HYALURONIC ACID

30

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

1.4 FL. OZ (41 mL)

HAWAIIAN TROPIC

OIL-FREE SUNSCREEN

SHEER TOUCH

FACE SERUM

LEAVES SKIN RADIANT

HYALURONIC ACID

30

CRUELTY FREE | VEGAN

BROAD SPECTRUM

SPF 30 UVA/UVB

1.4 FL. OZ (41 mL)

When Using This Product

keep out of eyes. Rinse with water to remove.

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

Purpose

Sunscreen Agent

Warnings

For external use only.

May stain some fabrics and surfaces.

Directions

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two 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 this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%, Homosalate 6.0%, Octisalate 4.5%,

Octocrylene 4.5%

Inactive Ingredients

Water, Silica, Propylene Glycol, Cetyl Dimethicone, Phenoxyethanol, Mica, Sodium Polyacrylate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Fragrance, Chlorphenesin, Glycerin, Disodium EDTA, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Hibiscus Sabdariffa Flower Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Titanium Dioxide.

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

if rash occurs.

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

HAWAIIAN TROPIC

OIL-FREE SUNSCREEN

SHEER TOUCH

FACE SERUM

LEAVES SKIN RADIANT

HYALURONIC ACID

30

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

1.4 FL. OZ (41 mL)

HAWAIIAN TROPIC

OIL-FREE SUNSCREEN

SHEER TOUCH

FACE SERUM

LEAVES SKIN RADIANT

HYALURONIC ACID

30

CRUELTY FREE | VEGAN

BROAD SPECTRUM

SPF 30 UVA/UVB

1.4 FL. OZ (41 mL)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:50.503896 · Updated: 2026-03-14T23:09:50.407692