DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Water Alcohol Propylene Glycol Laurate Bht Peg-400

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-08

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

Uses

Helps prevent sunburn.

|f used as directed with other sun protection measures (see Directions)decreases the risk of skin cancer and early skin aging caused by the sun.

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

Section 50567-7

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.

Section 50570-1

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

Stop use and ask a doctor if rash occurs.

Section 51727-6

WATER

BHT

ALCOHOL

PEG-400

PROPYLENE GLYCOL LAURATE

Section 51945-4

Section 55105-1

Sunscreen+ Setting Spritz

Section 55106-9

AVOBENZONE G63QQF2NOX 2.9%

OCTISALATE 4X49Y0596W 4.9%

OCTOCRYLENE 5A68WGF6WM 9.5%

Structured Label Content

Indications and Usage (34067-9)

Uses

Helps prevent sunburn.

|f used as directed with other sun protection measures (see Directions)decreases the risk of skin cancer and early skin aging caused by the sun.

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

Section 50567-7 (50567-7)

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.

Section 50570-1 (50570-1)

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

Stop use and ask a doctor if rash occurs.

Section 51727-6 (51727-6)

WATER

BHT

ALCOHOL

PEG-400

PROPYLENE GLYCOL LAURATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen+ Setting Spritz

Section 55106-9 (55106-9)

AVOBENZONE G63QQF2NOX 2.9%

OCTISALATE 4X49Y0596W 4.9%

OCTOCRYLENE 5A68WGF6WM 9.5%

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Helps prevent sunburn. |f used as directed with other sun protection measures (see Directions)decreases the risk of skin cancer and early skin aging caused by the sun.", "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", "50567-7": "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.", "50570-1": "When using this product: keep out of eyes, Rinse with water to remave. Stop use and ask a doctor if rash occurs.", "51727-6": "WATER BHT ALCOHOL PEG-400 PROPYLENE GLYCOL LAURATE", "55105-1": "Sunscreen+ Setting Spritz", "55106-9": "AVOBENZONE G63QQF2NOX 2.9% OCTISALATE 4X49Y0596W 4.9% OCTOCRYLENE 5A68WGF6WM 9.5%"}