SPL v1
SPL
SPL Set ID 3c439584-5b59-329d-e063-6294a90a8a5a
Route
TOPICAL
Published
Effective Date 2025-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Avobenzone (3 g) Octisalate (5 g)
Inactive Ingredients
Denatonium Benzoate Parfumidine Isopropyl Myristate Isobutane Ethylhexyl Triazone .alpha.-tocopherol Acetate, D- Panthenol Acrylates/octylacrylamide Copolymer (75000 Mw) 1,3-bis(diphenylphosphino)propane 1,3-butanedithiol

Identifiers & Packaging

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

Description

Alcohol Denat. , Isopropyl Myristate , Butane , Isobutane , Propane , Ethylhexyl Triazone Acrylates/Octylacrylamide Copolymer , Parfum , Tocopheryl Acetate , Panthenol


Medication Information

Description

Alcohol Denat. , Isopropyl Myristate , Butane , Isobutane , Propane , Ethylhexyl Triazone Acrylates/Octylacrylamide Copolymer , Parfum , Tocopheryl Acetate , Panthenol

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.

Section 55105-1

Helps prevent sunburn

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this Product Keep away from face to avoid breathing it

Keep out of eyes.Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Flammable

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 F . Do not use in the presence of a flame or spark . Keep away from sources of ignition-No smoking . Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

Shake well . Hold container 4 or 6 inches from the skin to apply. Spray liberally and spread evenly by hand 15 minutes before sun exposure. Do not spray directly into face. Spray on hands and then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.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.

Sun Screen Spray

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

Inactive Ingredients

Alcohol Denat. , Isopropyl Myristate , Butane , Isobutane , Propane , Ethylhexyl Triazone

Acrylates/Octylacrylamide Copolymer , Parfum , Tocopheryl Acetate , Panthenol

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

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.

Section 55105-1 (55105-1)

Helps prevent sunburn

Warnings (WARNINGS)

For external use only.

Do not use on damaged or broken skin.

When using this Product Keep away from face to avoid breathing it

Keep out of eyes.Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Flammable

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 F . Do not use in the presence of a flame or spark . Keep away from sources of ignition-No smoking . Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

Shake well . Hold container 4 or 6 inches from the skin to apply. Spray liberally and spread evenly by hand 15 minutes before sun exposure. Do not spray directly into face. Spray on hands and then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.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.

Sun Screen Spray (SUN SCREEN SPRAY)

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

Inactive Ingredients

Alcohol Denat. , Isopropyl Myristate , Butane , Isobutane , Propane , Ethylhexyl Triazone

Acrylates/Octylacrylamide Copolymer , Parfum , Tocopheryl Acetate , Panthenol

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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