1520a151-70c4-8699-e063-6294a90adc6b

SPL v1
SPL
SPL Set ID 1520a151-70c4-8699-e063-6294a90adc6b
Route
topical
Published
Effective Date 2024-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) octocrylene (9 g) octisalate (5 g)
Inactive Ingredients
eugenia uniflora fruit leuconostoc/radish root ferment filtrate sodium benzoate alcohol polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) diheptyl succinate capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) potassium sorbate acrylates/octylacrylamide copolymer (40000 mw) ethyl ferulate niacinamide levomenol butyloctyl salicylate ethylhexyl methoxycrylene pongamia pinnata seed coconut water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-27

Description

Drug Facts Active Ingredients Purpose Avobenzone (3.00%)......Sunscreen Octisalate (5.00%)..........Sunscreen Octocrylene (9.00%).......Sunscreen


Medication Information

Warnings and Precautions

Warnings:

• For external use only.

• Do not use on damaged or broken skin.

• When using this product 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.

• Flammable. Contents under pressure. Do not use near heat or flame.

• Do not puncture or incinerate. Do not store at temperatures above 120°F.

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 10am - 2pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Active Ingredient

Drug Facts

Active Ingredients Purpose

Avobenzone (3.00%)......Sunscreen

Octisalate (5.00%)..........Sunscreen

Octocrylene (9.00%).......Sunscreen

Indications and Usage

Uses:

• Helps prevent sunburn.

Directions:

• Apply generously and evenly 15 minutes before sun exposure.

• Children under 6 months of age: ask a doctor.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

Dosage and Administration

Dosage: Evenly and generously apply to skin.

Administration: Topical

Description

Drug Facts Active Ingredients Purpose Avobenzone (3.00%)......Sunscreen Octisalate (5.00%)..........Sunscreen Octocrylene (9.00%).......Sunscreen

Section 50565-1

Keep out of reach of children.

Section 51727-6

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Bisabolol, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Cocos Nucifera (Coconut) Water, Diheptyl Succinate, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Eugenia Uniflora Fruit Extract, Leuconostoc/Radish Root Ferment Filtrate, Niacinamide, Parfum (Fragrance), Polyester-8, Pongamia Pinnata Seed Extract, Potassium Sorbate, Sodium Benzoate, Benzyl Salicylate, Citronellol, Limonene.

Section 51945-4

Section 55105-1

Sunscreen


Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

• For external use only.

• Do not use on damaged or broken skin.

• When using this product 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.

• Flammable. Contents under pressure. Do not use near heat or flame.

• Do not puncture or incinerate. Do not store at temperatures above 120°F.

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 10am - 2pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Active Ingredient (55106-9)

Drug Facts

Active Ingredients Purpose

Avobenzone (3.00%)......Sunscreen

Octisalate (5.00%)..........Sunscreen

Octocrylene (9.00%).......Sunscreen

Indications and Usage (34067-9)

Uses:

• Helps prevent sunburn.

Directions:

• Apply generously and evenly 15 minutes before sun exposure.

• Children under 6 months of age: ask a doctor.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

Dosage and Administration (34068-7)

Dosage: Evenly and generously apply to skin.

Administration: Topical

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Bisabolol, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Cocos Nucifera (Coconut) Water, Diheptyl Succinate, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Eugenia Uniflora Fruit Extract, Leuconostoc/Radish Root Ferment Filtrate, Niacinamide, Parfum (Fragrance), Polyester-8, Pongamia Pinnata Seed Extract, Potassium Sorbate, Sodium Benzoate, Benzyl Salicylate, Citronellol, Limonene.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen


Advanced Ingredient Data


Raw Label Data

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