SPL v1
SPL
SPL Set ID 6ccc1c4f-906f-17d1-e053-2991aa0a4c6a
Route
TOPICAL
Published
Effective Date 2018-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (8 g) Octisalate (4 g) Oxybenzone (5 g) Octocrylene
Inactive Ingredients
Dimethicone Alcohol Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Neopentyl Glycol Diheptanoate Cyclomethicone 5 Ascorbyl Palmitate Vitamin A Palmitate Polyester-7 Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-14

Description

Avobenzone 3%, Homosalate 8%, Octisalate 4%, Octocrylene 8%, Oxybenzone 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 8%, Octisalate 4%, Octocrylene 8%, Oxybenzone 5%

Use

Helps prevent sunburn.

Label

Warnings

For external use only.

Flammable: do not use near heat, flame, or while smoking. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Keep away from face to avoid breathing it. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F. Stop use and ask a doctor if rash occurs.

Directions

Spray liberally and evenly by hand 15 minutes before sun exposure.

Reapply after:

80 minutes of sweating or swimming



immediately after towel drying



at least every 2 hours

Hold can 4-6 inches from the skin to apply. Do not spray directly into your face. Spray on hands an then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.

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.

Active Ingredients

Avobenzone 3%, Homosalate 8%, Octisalate 4%, Octocrylene 8%, Oxybenzone 5%

Inactive Ingredients

Acrylates/Dimethicone Copolymer, Acrylates Octylacrylamide Copolymer, Alcohol Denat., Ascorbyl Palmitate, Cyclopentasiloxane, Fragrance, Neopentyl Glycol Diheptanoate, Octyldodecyl Citrate Crosspolymer, Polyester-7, Polyester-8, Retinyl Palmitate, Tocopheryl Acetate.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

Helps prevent sunburn.

Label

Purpose

Sunscreen

Warnings

For external use only.

Flammable: do not use near heat, flame, or while smoking. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Keep away from face to avoid breathing it. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F. Stop use and ask a doctor if rash occurs.

Directions

Spray liberally and evenly by hand 15 minutes before sun exposure.

Reapply after:

80 minutes of sweating or swimming



immediately after towel drying



at least every 2 hours

Hold can 4-6 inches from the skin to apply. Do not spray directly into your face. Spray on hands an then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.

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.

Active Ingredients

Avobenzone 3%, Homosalate 8%, Octisalate 4%, Octocrylene 8%, Oxybenzone 5%

Inactive Ingredients

Acrylates/Dimethicone Copolymer, Acrylates Octylacrylamide Copolymer, Alcohol Denat., Ascorbyl Palmitate, Cyclopentasiloxane, Fragrance, Neopentyl Glycol Diheptanoate, Octyldodecyl Citrate Crosspolymer, Polyester-7, Polyester-8, Retinyl Palmitate, Tocopheryl Acetate.

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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