dc7b0d17-d7c8-433f-e053-2995a90a477d

SPL v3
SPL
SPL Set ID dc7b0d17-d7c8-433f-e053-2995a90a477d
Route
topical
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (4.5 g) avobenzone (2.7 g) octocrylene (7 g) homosalate (9 g)
Inactive Ingredients
dimethicone .alpha.-tocopherol acetate panthenol alkyl (c12-15) benzoate caprylyl glycol water ascorbyl palmitate isododecane aloe vera leaf alcohol mineral oil isobutane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-04-12

Purpose

Sunscreen

Description

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


Medication Information

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. Intentional misuse by

deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics.

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

Directions
  • 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 ofswimming 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
Other Information

protect this product from excessive heat and direct sun

Description

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

Principal Display Panel

BANANA

BOAT

KiDS

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 65

65

PEDIATRICIAN TESTED

Lightweight Feel

High Endurance vs. Water

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170g)

Do Not Use

on damaged or broken skin.

Active Ingredients

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

Inactive Ingredients:

Alcohol Denat., Isobutane, C12-15 Alkyl Benzoate, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Ascorbyl Palmitate, Tocopheryl Acetate, Mineral Oil, Water, Panthenol, Aloe Barbadensis Leaf Extract.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

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

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. Intentional misuse by

deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics.

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

Directions
  • 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 ofswimming 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
Other Information

protect this product from excessive heat and direct sun

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT

KiDS

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 65

65

PEDIATRICIAN TESTED

Lightweight Feel

High Endurance vs. Water

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170g)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

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

Inactive Ingredients:

Alcohol Denat., Isobutane, C12-15 Alkyl Benzoate, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Ascorbyl Palmitate, Tocopheryl Acetate, Mineral Oil, Water, Panthenol, Aloe Barbadensis Leaf Extract.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

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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