SPL v3
SPL
SPL Set ID dc64918f-df4c-3a5e-e053-2995a90aea4b
Route
TOPICAL
Published
Effective Date 2022-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (5 g) Octocrylene (3.5 g) Avobenzone (1.5 g)
Inactive Ingredients
Lauryl Peg-8 Dimethicone (300 Cps) Dehydrated Alcohol Guava Papaya Mineral Oil Caprylyl Glycol Panthenol Aloe Vera Leaf Isododecane Diisopropyl Adipate Passiflora Incarnata Fruit Isobutane Colocasia Esculenta Root Mango Plumeria Rubra Flower Water Methyl Dihydroabietate .alpha.-tocopherol Acetate Ascorbyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-10-01 Until 2026-10-31

Description

Avobenzone 1.5%, Homosalate 5.0%, Octocrylene 3.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 1.5%, Homosalate 5.0%, Octocrylene 3.5%

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

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

May stain some fabrics and surfaces.

Warnings

For external use only

Direction

• 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 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 1.5%, Homosalate 5.0%, Octocrylene 3.5%

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Caprylyl Glycol, Fragrance, Methyl Dihydroabietate, Mineral Oil, Ascorbyl Palmitate, Tocopheryl Acetate, Panthenol, Water, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root 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(R)

SPORT SUNSCREEN SPRAY

EVERYDAY

ACTIVE(TM)

SWEAT | WATER RESISTANT

(80 MINUTES)

15

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 15 UVA/UVB

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.


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

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

May stain some fabrics and surfaces.

Purpose

Sunscreen

Warnings

For external use only

Direction

• 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 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 1.5%, Homosalate 5.0%, Octocrylene 3.5%

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Caprylyl Glycol, Fragrance, Methyl Dihydroabietate, Mineral Oil, Ascorbyl Palmitate, Tocopheryl Acetate, Panthenol, Water, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root 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 (PRINCIPAL DISPLAY PANEL)

HAWAIIAN

TROPIC(R)

SPORT SUNSCREEN SPRAY

EVERYDAY

ACTIVE(TM)

SWEAT | WATER RESISTANT

(80 MINUTES)

15

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 15 UVA/UVB

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.


Advanced Ingredient Data


Raw Label Data

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