SPL v4
SPL
SPL Set ID dc9d6c88-d3f3-a0ca-e053-2a95a90a7a23
Route
TOPICAL
Published
Effective Date 2022-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (4 g) Octisalate (4.5 g) Homosalate (5.5 g) Avobenzone (2 g)
Inactive Ingredients
Ascorbyl Palmitate Water Diisopropyl Adipate .alpha.-tocopherol Acetate Aloe Vera Leaf Mango Passiflora Incarnata Fruit Dehydrated Alcohol Mineral Oil Plumeria Rubra Flower Isododecane Dimethicone Hydroxypropyl Cellulose, Unspecified Panthenol Glyceryl Oleate Papaya Guava Isobutane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-14

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% .

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% .

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 120F. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

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 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 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% .

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Dimethicone, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Hydroxypropylcellulose, Mineral Oil, Tocopheryl Acetate, Ascorbyl Palmitate, Panthenol, Water, 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

Silk

HYDRATION

Clear Spray Sunscreen

WEIGHTLESS

Feels as if it's a barely on

30

BROAD SPECTRUM

SPF30

12 HOUR

Moisturization

with UVA/UVB Protection

Fast absorbing

Water resistant

(80 Minutes)

NET WT 60Z. (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. 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.

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 120F. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

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 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 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% .

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Dimethicone, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Hydroxypropylcellulose, Mineral Oil, Tocopheryl Acetate, Ascorbyl Palmitate, Panthenol, Water, 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 (PRINCIPAL DISPLAY PANEL)

HAWAIIAN

Tropic

Silk

HYDRATION

Clear Spray Sunscreen

WEIGHTLESS

Feels as if it's a barely on

30

BROAD SPECTRUM

SPF30

12 HOUR

Moisturization

with UVA/UVB Protection

Fast absorbing

Water resistant

(80 Minutes)

NET WT 60Z. (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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal


Advanced Ingredient Data


Raw Label Data

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