SPL v2
SPL
SPL Set ID e5fcb1fd-ad61-1ea5-e053-2a95a90a2472
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (7 g) Homosalate (9 g) Octisalate (4.5 g) Avobenzone (2.7 g)
Inactive Ingredients
Niacinamide Caprylyl Glycol .alpha.-tocopherol Acetate Aloe Vera Leaf Tetrahexyldecyl Ascorbate Mineral Oil Panthenol Water Medium-chain Triglycerides Dimethicone Dehydrated Alcohol Isododecane Green Tea Leaf Isobutane

Identifiers & Packaging

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

Description

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

Purpose

Sunscreen Agent


Medication Information

Purpose

Sunscreen Agent

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.

May stain some fabrics.



Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 °F.

Flammable: 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 and 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 • Children under 6 months: Ask a doctor • 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

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, Caprylic/Capric Triglyceride, Isododecane, Niacinamide, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone,Tetrahexyldecyl Ascorbate, Camellia Sinensis Leaf Extract, Fragrance,Tocopheryl Acetate, Mineral Oil, Panthenol,Water, Aloe Barbadensis Leaf Extract

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT

NEW!

Protection

+Vitamins

SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

VITAMINS

C + B3

12 HOUR HYDRATION

NOURISH + PROTECT

FROM UV DAMAGE

Water Resistant

(80 Minutes)

4.5 FL.OZ (133mL)

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 skin aging caused by the sun.
Purpose

Sunscreen Agent

Warnings

For external use only.

May stain some fabrics.



Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 °F.

Flammable: 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 and 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 • Children under 6 months: Ask a doctor • 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

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, Caprylic/Capric Triglyceride, Isododecane, Niacinamide, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone,Tetrahexyldecyl Ascorbate, Camellia Sinensis Leaf Extract, Fragrance,Tocopheryl Acetate, Mineral Oil, Panthenol,Water, Aloe Barbadensis Leaf Extract

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT

NEW!

Protection

+Vitamins

SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

VITAMINS

C + B3

12 HOUR HYDRATION

NOURISH + PROTECT

FROM UV DAMAGE

Water Resistant

(80 Minutes)

4.5 FL.OZ (133mL)

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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