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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

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.

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.

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
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, 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

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)

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

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.

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
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, 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

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)

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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