3c451006-5976-d016-e063-6394a90a12a3

SPL v1
SPL
SPL Set ID 3c451006-5976-d016-e063-6394a90a12a3
Route
topical
Published
Effective Date 2025-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) octisalate (5 g) octinoxate (7.5 g)
Inactive Ingredients
ethylhexyl stearate ethylhexylglycerin aqua ethylhexyl triazone sodium hydroxide phenoxyethanol acrylic acid/2-ethylhexyl acrylate/styrene copolymer (500000 mw) glyceryl stearate peg-100 stearate cetearyl alcohol panthenol parfumidine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-01-05

Purpose

Sunscreen

Description

Aqua , Ethylhexyl Triazone, Ethylhexyl Stearate ,Styrene/Acrylates Copolymer , Glyceryl Stearate , PEG-100 Stearate , Cetearyl Alcohol , Acrylates/ Copolymer , Phenoxyethanol ,Parfum , Ethylhexylglycerin ,Panthenol , Sodium Hydroxide.


Medication Information

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.

Uses

Helps prevent sunburn

If used as directed with other sun proctection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Inactive Ingredients

Aqua , Ethylhexyl Triazone, Ethylhexyl Stearate ,Styrene/Acrylates Copolymer , Glyceryl Stearate , PEG-100 Stearate , Cetearyl Alcohol , Acrylates/ Copolymer , Phenoxyethanol ,Parfum , Ethylhexylglycerin ,Panthenol , Sodium Hydroxide.

Description

Aqua , Ethylhexyl Triazone, Ethylhexyl Stearate ,Styrene/Acrylates Copolymer , Glyceryl Stearate , PEG-100 Stearate , Cetearyl Alcohol , Acrylates/ Copolymer , Phenoxyethanol ,Parfum , Ethylhexylglycerin ,Panthenol , Sodium Hydroxide.

Section 51945-4

Direction

Apply generously 15 minutes before sun exposure. reapply : after 80 minutes of swimming 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 board 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.

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

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 board 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.

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.

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.

Uses

Helps prevent sunburn

If used as directed with other sun proctection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Inactive Ingredients

Aqua , Ethylhexyl Triazone, Ethylhexyl Stearate ,Styrene/Acrylates Copolymer , Glyceryl Stearate , PEG-100 Stearate , Cetearyl Alcohol , Acrylates/ Copolymer , Phenoxyethanol ,Parfum , Ethylhexylglycerin ,Panthenol , Sodium Hydroxide.

Section 51945-4 (51945-4)

Direction

Apply generously 15 minutes before sun exposure. reapply : after 80 minutes of swimming 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 board 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.

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

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 board 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.

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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