SPL v1
SPL
SPL Set ID 3c2ecee5-d860-158f-e063-6294a90a5120
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) Octinoxate (7.5 g) Octisalate (5 g)
Inactive Ingredients
Ethylhexyl Triazone Phenoxyethanol Aqua Panthenol Ethylhexylglycerin Parfumidine Ethylhexyl Stearate Glyceryl Stearate Acrylates Crosspolymer-4 Cetearyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-05

Description

Aqua , Ethylhexyl Triazone , Ethylhexyl Stearate , Phenoxyethanol , Glyceryl Stearate , Acrylates Copolymer , Cetearyl Alcohol , Styrene/Acrylates Copolymer , Parfum , Ethylhexylglycerin ,Panthenol ,Tocopheryl Acetate.

Purpose

Helps prevent sunburn


Medication Information

Purpose

Helps prevent sunburn

Description

Aqua , Ethylhexyl Triazone , Ethylhexyl Stearate , Phenoxyethanol , Glyceryl Stearate , Acrylates Copolymer , Cetearyl Alcohol , Styrene/Acrylates Copolymer , Parfum , Ethylhexylglycerin ,Panthenol ,Tocopheryl Acetate.

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.

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.

Directions

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.

Other Warnings

Protect this Product from excessive heat and direct sun

May stain some fabrics

Sun Screen Spray

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

Inactive Ingredients

Aqua , Ethylhexyl Triazone ,

Ethylhexyl Stearate , Phenoxyethanol , Glyceryl Stearate , Acrylates Copolymer , Cetearyl Alcohol , Styrene/Acrylates Copolymer , Parfum , Ethylhexylglycerin ,Panthenol ,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

Uses (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

Helps prevent sunburn

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.

Directions

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.

Other Warnings

Protect this Product from excessive heat and direct sun

May stain some fabrics

Sun Screen Spray (SUN SCREEN SPRAY)

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

Inactive Ingredients

Aqua , Ethylhexyl Triazone ,

Ethylhexyl Stearate , Phenoxyethanol , Glyceryl Stearate , Acrylates Copolymer , Cetearyl Alcohol , Styrene/Acrylates Copolymer , Parfum , Ethylhexylglycerin ,Panthenol ,Tocopheryl Acetate.

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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