SPL v1
SPL
SPL Set ID 3cf3e27d-ab16-4f12-e063-6394a90a70e2
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9 g) Octisalate (4.5 g) Octocrylene (6.5 g) Avobenzone (3 g)
Inactive Ingredients
Guava Silicon Dioxide Cetyl Dimethicone/bis-vinyldimethicone Crosspolymer Mica Titanium Dioxide Edetate Disodium Anhydrous Water Propylene Glycol Phenoxyethanol Acrylic Acid Caprylyl Glycol Papaya Mango Chlorphenesin Aloe Vera Leaf Hyaluronate Sodium Passiflora Incarnata Fruit Plumeria Rubra Flower Hibiscus Sabdariffa Flower Sodium Polyacrylate (2500000 Mw) Glycerin

Identifiers & Packaging

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

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Purpose

Sunscreen Agent


Medication Information

Purpose

Sunscreen Agent

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

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 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

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(R)

INVISIBLE SUNSCREEN

SHEER TOUCH

SERUM

LEAVES SKIN RADIANT

HYALURONIC ACID

50

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

3.3 FL. OZ (97 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 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

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(R)

INVISIBLE SUNSCREEN

SHEER TOUCH

SERUM

LEAVES SKIN RADIANT

HYALURONIC ACID

50

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

3.3 FL. OZ (97 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)