SPL v2
SPL
SPL Set ID 090904d1-c04c-3fca-e063-6294a90a7cc7
Route
TOPICAL
Published
Effective Date 2023-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9 g) Octocrylene (7 g) Octisalate (4.5 g) Avobenzone (2.7 g)
Inactive Ingredients
Mineral Oil Glyceryl Oleate Aloe Vera Leaf Plumeria Rubra Flower Guava Ascorbyl Palmitate Caprylyl Glycol Passiflora Incarnata Fruit Isobutane Isododecane Water Alkyl (c12-15) Benzoate Alpha-tocopherol Acetate Mango Dimethicone Alcohol Panthenol Papaya

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-31

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%

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: Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 oF. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics and surfaces.

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 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 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 9.0%, Octisalate 4.5%, Octocrylene 7.0%

Inactive Ingredients:

Alcohol Denat., Isobutane, Isododecane, C12-15 Alkyl Benzoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Mineral Oil, Water, Panthenol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract.

Questions Or Comments?

Call 1-800-NO-UVRAY, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC (R)

SUNSCREEN CLEAR SPRAY

WEIGHTLESS

HYDRATION

12HR MOISTURIZATION*

ISLAND BOTANICALS

50

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

NET WT 6 OZ (170 g)

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 and surfaces.


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: Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 oF. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics and surfaces.

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 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 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 9.0%, Octisalate 4.5%, Octocrylene 7.0%

Inactive Ingredients:

Alcohol Denat., Isobutane, Isododecane, C12-15 Alkyl Benzoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Mineral Oil, Water, Panthenol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract.

Questions Or Comments? (Questions or Comments?)

Call 1-800-NO-UVRAY, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC (R)

SUNSCREEN CLEAR SPRAY

WEIGHTLESS

HYDRATION

12HR MOISTURIZATION*

ISLAND BOTANICALS

50

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

NET WT 6 OZ (170 g)

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 and surfaces.


Advanced Ingredient Data


Raw Label Data

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