SPL v2
SPL
SPL Set ID 203c780a-3107-d71a-e063-6394a90aca25
Route
TOPICAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.5 g) Homosalate (3 g) Octisalate (1 g) Octocrylene
Inactive Ingredients
Hydroxypropyl Cellulose, Unspecified .alpha.-tocopherol Acetate Ascorbyl Palmitate Coconut Oil Medium-chain Triglycerides Mineral Oil Papaya Passiflora Incarnata Fruit Guava Mango Isododecane Plumeria Rubra Flower Dimethicone Aloe Vera Leaf Alcohol Isobutane Diisopropyl Adipate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Avobenzone 1.5%, Homosalate 3.0%, Octisalate 1.0%, Octocrylene 3.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 1.5%, Homosalate 3.0%, Octisalate 1.0%, Octocrylene 3.0%

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

Flammable: Contents under pressure. Do not puncture or incinerate. Do not expose to heat, or store at temperatures above 120°F. Do not use in the presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics.

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in a well ventilated area • 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 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-sleeve 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 1.5%, Homosalate 3.0%, Octisalate 1.0%, Octocrylene 3.0%

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Dimethicone, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Hydroxypropylcellulose, Tocopheryl Acetate, Ascorbyl Palmitate, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Mineral Oil, Aloe Barbadensis Leaf Extract, 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, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC

SUNSCREEN DRY OIL SPRAY

PROTECTIVE TANNING

ENHANCE TAN & MOISTURE

COCONUT OIL

15

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 15 UVA / UVB

WATER RESISTANT (80 MINUTES)

NET WT 6.0 OZ (170g)

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 aging caused by the sun.

Purpose

Sunscreen

Warnings

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate. Do not expose to heat, or store at temperatures above 120°F. Do not use in the presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics.

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in a well ventilated area • 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 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-sleeve 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 1.5%, Homosalate 3.0%, Octisalate 1.0%, Octocrylene 3.0%

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Dimethicone, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Hydroxypropylcellulose, Tocopheryl Acetate, Ascorbyl Palmitate, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Mineral Oil, Aloe Barbadensis Leaf Extract, 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, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC

SUNSCREEN DRY OIL SPRAY

PROTECTIVE TANNING

ENHANCE TAN & MOISTURE

COCONUT OIL

15

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 15 UVA / UVB

WATER RESISTANT (80 MINUTES)

NET WT 6.0 OZ (170g)

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

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