DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (1.74 g) Octisalate (2.94 g) Octocrylene (5.7 g)

Inactive Ingredients

Propylene Glycol Laurate Alcohol Bht Polyethylene Glycol 400 Aqua

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2024-12-15 Until 2028-11-10

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.lf swallowed, get medical help or contacta Poison Control

Center right away

Flammable. Do not spray near heat sparks, sources of ignition, or flames

Indications and Usage

Directions

Apply liberally 15 minutes before sun exposure. Reaooly. at least every 2 hours or after

80 minutes ofswimming or sweating.Sun Protection Measures, Spending time in the sun

increases your riskof skan cancer and early skin aging. lo decrease this risk, regularly

use asunscreen with a Broad Spectrum SPF value of 15 or higher and other

sunprotection measures including, limit time in sun, especiallv from 10 a.m.-2p.m, and

wear long-sleeved shirts, pants, hats, and sunalasses. Chitdrenunder 6 months of age:

ask a doctor.

Dosage and Administration

Apply tiberally 15 minutes before sun exposure.

Reapoly. at least every 2 hours or after 80 minutes of swimming or sweating.

Description

AVOBENZONE G63QQF2NOX 2.9% OCTISALATE 4X49Y0596W 4.9% OCTOCRYLENE 5A68WGF6WM 9.5%

Section 50565-1

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control

Center right away

Flammable. Do not spray near heat sparks, sources of ignition, or flames

Section 50566-9

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.

Section 50567-7

When using this product: keep out of eyes, Rinse with water to remave.

Stop use and ask a doctor if rash occurs.

Section 50570-1

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control

Center right away

Flammable. Do not spray near heat sparks, sources of ignition, or flames

Section 51727-6

WATER

BHT

ALCOHOL

PEG-400

PROPYLENE GLYCOL LAURATE

Section 51945-4

Section 55105-1

WATER

BHT

ALCOHOL

PEG-400

PROPYLENE GLYCOL LAURATE

Section 55106-9

AVOBENZONE G63QQF2NOX 2.9%

OCTISALATE 4X49Y0596W 4.9%

OCTOCRYLENE 5A68WGF6WM 9.5%

Structured Label Content

Indications and Usage (34067-9)

Directions

Apply liberally 15 minutes before sun exposure. Reaooly. at least every 2 hours or after

80 minutes ofswimming or sweating.Sun Protection Measures, Spending time in the sun

increases your riskof skan cancer and early skin aging. lo decrease this risk, regularly

use asunscreen with a Broad Spectrum SPF value of 15 or higher and other

sunprotection measures including, limit time in sun, especiallv from 10 a.m.-2p.m, and

wear long-sleeved shirts, pants, hats, and sunalasses. Chitdrenunder 6 months of age:

ask a doctor.

Dosage and Administration (34068-7)

Apply tiberally 15 minutes before sun exposure.

Reapoly. at least every 2 hours or after 80 minutes of swimming or sweating.

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.lf swallowed, get medical help or contacta Poison Control

Center right away

Flammable. Do not spray near heat sparks, sources of ignition, or flames

Section 50565-1 (50565-1)

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control

Center right away

Flammable. Do not spray near heat sparks, sources of ignition, or flames

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product: keep out of eyes, Rinse with water to remave.

Stop use and ask a doctor if rash occurs.

Section 50570-1 (50570-1)

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control

Center right away

Flammable. Do not spray near heat sparks, sources of ignition, or flames

Section 51727-6 (51727-6)

WATER

BHT

ALCOHOL

PEG-400

PROPYLENE GLYCOL LAURATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

WATER

BHT

ALCOHOL

PEG-400

PROPYLENE GLYCOL LAURATE

Section 55106-9 (55106-9)

AVOBENZONE G63QQF2NOX 2.9%

OCTISALATE 4X49Y0596W 4.9%

OCTOCRYLENE 5A68WGF6WM 9.5%

Advanced Ingredient Data

[{"name": "PROPYLENE GLYCOL LAURATE", "unii": "668Z5835Z3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "1.74", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BHT", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2.94", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "5.7", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AQUA", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions Apply liberally 15 minutes before sun exposure. Reaooly. at least every 2 hours or after 80 minutes ofswimming or sweating.Sun Protection Measures, Spending time in the sun increases your riskof skan cancer and early skin aging. lo decrease this risk, regularly use asunscreen with a Broad Spectrum SPF value of 15 or higher and other sunprotection measures including, limit time in sun, especiallv from 10 a.m.-2p.m, and wear long-sleeved shirts, pants, hats, and sunalasses. Chitdrenunder 6 months of age: ask a doctor.", "34068-7": "Apply tiberally 15 minutes before sun exposure. Reapoly. at least every 2 hours or after 80 minutes of swimming or sweating.", "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.lf swallowed, get medical help or contacta Poison Control Center right away Flammable. Do not spray near heat sparks, sources of ignition, or flames", "50565-1": "Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away Flammable. Do not spray near heat sparks, sources of ignition, or flames", "50566-9": "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.", "50567-7": "When using this product: keep out of eyes, Rinse with water to remave. Stop use and ask a doctor if rash occurs.", "50570-1": "Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away Flammable. Do not spray near heat sparks, sources of ignition, or flames", "51727-6": "WATER BHT ALCOHOL PEG-400 PROPYLENE GLYCOL LAURATE", "55105-1": "WATER BHT ALCOHOL PEG-400 PROPYLENE GLYCOL LAURATE", "55106-9": "AVOBENZONE G63QQF2NOX 2.9% OCTISALATE 4X49Y0596W 4.9% OCTOCRYLENE 5A68WGF6WM 9.5%"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information