SPL v5
SPL
SPL Set ID e686a22f-bddc-5d7c-e053-2995a90a7b28
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9.5 g) Octisalate (4.7 g) Octocrylene (7.5 g) Avobenzone (2.8 g)
Inactive Ingredients
Isododecane Butyloctyl Salicylate Caprylyl Glycol Dimethicone Dehydrated Alcohol Medium-chain Triglycerides Alpha-tocopherol Acetate Ascorbyl Palmitate Mineral Oil Panthenol Water Aloe Vera Leaf Papaya Mango Passiflora Incarnata Fruit Plumeria Rubra Flower Guava Isobutane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01

Description

Avobenzone 2.8%, Homosalate 9.5%, Octisalate 4.7%, Octocrylene 7.5% .

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.8%, Homosalate 9.5%, Octisalate 4.7%, Octocrylene 7.5% .

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

Flammable: Contents under pressure. Do not puncture or incinerate container. 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.

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 2.8%, Homosalate 9.5%, Octisalate 4.7%, Octocrylene 7.5% .

Inactive Ingredients

Alcohol Denat., Isobutane, Caprylic/Capric Triglyceride, Isododecane, Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Mineral Oil, Panthenol, Water, 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-UVRAY, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC

SUNSCREEN CLEAR SPRAY

WEIGHTLESS HYDRATION

12 HR MOISTURIZATION*

ISLAND BOTANICALS

70

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 70 UVA/UVB

WATER RESISTANT (80 MINUTES)

NET WT 6 OZ (170 g)

When Using This Product

• Keep away from face to avoid breathing it

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 F. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

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 2.8%, Homosalate 9.5%, Octisalate 4.7%, Octocrylene 7.5% .

Inactive Ingredients

Alcohol Denat., Isobutane, Caprylic/Capric Triglyceride, Isododecane, Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Mineral Oil, Panthenol, Water, 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-UVRAY, Mon-Fri

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

HAWAIIAN

TROPIC

SUNSCREEN CLEAR SPRAY

WEIGHTLESS HYDRATION

12 HR MOISTURIZATION*

ISLAND BOTANICALS

70

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 70 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

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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