SPL v1
SPL
SPL Set ID 6ce1a30c-b1c7-e112-e053-2a91aa0a1888
Route
TOPICAL
Published
Effective Date 2018-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (15 g) Octisalate (5 g) Oxybenzone (6 g) Octocrylene (10 g)
Inactive Ingredients
Alcohol Glycerin Medium-chain Triglycerides Diethylhexyl Syringylidenemalonate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw)

Identifiers & Packaging

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

Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

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 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Inactive Ingredients

Acrylates/Octylacrylamide Crosspolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin.

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 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Inactive Ingredients

Acrylates/Octylacrylamide Crosspolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin.

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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