DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octisalate (2.5 g) Avobenzone (1.5 g) Homosalate (4.5 g) Octocrylene (3.5 g)

Inactive Ingredients

Edetate Disodium Potassium Cetyl Phosphate Butyloctyl Salicylate Phenoxyethanol Ammonium Acryloyldimethyltaurate/vp Copolymer Mica Coco Glucoside Silica Ethylhexylglycerin Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Propylene Glycol Glycerin Hydroxyacetophenone Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Cetostearyl Alcohol Ci 77891 Glyceryl Stearate Ci 77492 Triethoxycaprylylsilane Neopentyl Glycol Diheptanoate Peg-100 Stearate Ci 77499 Ci 77491

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-01

Medication Information

Warnings and Precautions

For external use only Do not use on damaged !i or broken skin.

When using this product keep out of eyes.Rise 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 contact a Poison

ControlCenter right away

Indications and Usage

Directions

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

80 minutes of swimming or sweating. Sun Protection Measures: $pending time in the

sun increases your risk of skin cancer andearly skin aging. To decrease this risk,

regularly use a sunscreen with a Broad Spectrum SPfof 15 or higher and other sun

protection measures including: limit time in the sun, especiallyfrom 10 a.m.-2 pm, and

wear long-sleeved shirts, pants, hats, and sunglasses. Childrenunder 6 months of age

ask a doctor.

Dosage and Administration

Apply liberally 15 minutes before sun exposure.

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

Description

AVOBENZONE G63QQF2NOX 3.0% OCTISALATE 4X49Y0596W 5.0% OCTOCRYLENE 5A68WGF6WM 7.0% HOMOSALATE V06SV4M95S 9%

Section 50565-1

Keep out of reach of children. lf swallowed, get medical help or contact a Poison

ControlCenter right away

Section 51727-6

WATER

BUTYLOCTYL SALICYLATE

NEOPENTYL GLYCOL DIHEPTANOATE

MICA

CI 77891

BUTYL METHOXYDIBENZOYLMETHANE

GLYCERIN

PROPYLENE GLYCOL

VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER

CETEARYL ALCOHOL

COCO-GLUCOSIDE

GLYCERYL STEARATE

PEG-100 STEARATE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

POTASSIUM CETYL PHOSPHATE

AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER

CETEARYL ALCOHOL

HYDROXYACETOPHENONE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

CI 77492

TRIETHOXYCAPRYLYLSILANE

DISODIUM EDTA

CI 77491

CI 77499

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

AVOBENZONE G63QQF2NOX 3.0%

OCTISALATE 4X49Y0596W 5.0%

OCTOCRYLENE 5A68WGF6WM 7.0%

HOMOSALATE V06SV4M95S 9%

Structured Label Content

Indications and Usage (34067-9)

Directions

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

80 minutes of swimming or sweating. Sun Protection Measures: $pending time in the

sun increases your risk of skin cancer andearly skin aging. To decrease this risk,

regularly use a sunscreen with a Broad Spectrum SPfof 15 or higher and other sun

protection measures including: limit time in the sun, especiallyfrom 10 a.m.-2 pm, and

wear long-sleeved shirts, pants, hats, and sunglasses. Childrenunder 6 months of age

ask a doctor.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure.

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

Warnings and Precautions (34071-1)

For external use only Do not use on damaged !i or broken skin.

When using this product keep out of eyes.Rise 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 contact a Poison

ControlCenter right away

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medical help or contact a Poison

ControlCenter right away

Section 51727-6 (51727-6)

WATER

BUTYLOCTYL SALICYLATE

NEOPENTYL GLYCOL DIHEPTANOATE

MICA

CI 77891

BUTYL METHOXYDIBENZOYLMETHANE

GLYCERIN

PROPYLENE GLYCOL

VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER

CETEARYL ALCOHOL

COCO-GLUCOSIDE

GLYCERYL STEARATE

PEG-100 STEARATE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

POTASSIUM CETYL PHOSPHATE

AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER

CETEARYL ALCOHOL

HYDROXYACETOPHENONE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

CI 77492

TRIETHOXYCAPRYLYLSILANE

DISODIUM EDTA

CI 77491

CI 77499

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

AVOBENZONE G63QQF2NOX 3.0%

OCTISALATE 4X49Y0596W 5.0%

OCTOCRYLENE 5A68WGF6WM 7.0%

HOMOSALATE V06SV4M95S 9%

Advanced Ingredient Data

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"V8A1AW0880", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCO GLUCOSIDE", "unii": "ICS790225B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICA", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)", "unii": "H895X08VNQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYACETOPHENONE", "unii": "G1L3HT4CMH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER", "unii": "9NH1UDD2RR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CI 77891", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "4.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CI 77492", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHOXYCAPRYLYLSILANE", "unii": "LDC331P08E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NEOPENTYL GLYCOL DIHEPTANOATE", "unii": "5LKW3C543X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CI 77499", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CI 77491", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions Apply liberally 15 minutes before sun exposure. Reapply: at least every 2 hours or after 80 minutes of swimming or sweating. Sun Protection Measures: $pending time in the sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPfof 15 or higher and other sun protection measures including: limit time in the sun, especiallyfrom 10 a.m.-2 pm, and wear long-sleeved shirts, pants, hats, and sunglasses. Childrenunder 6 months of age ask a doctor.", "34068-7": "Apply liberally 15 minutes before sun exposure. Reapply: at least every 2 hours or after 80 minutes of swimming or sweating.", "34071-1": "For external use only Do not use on damaged !i or broken skin. When using this product keep out of eyes.Rise 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 contact a Poison ControlCenter right away", "50565-1": "Keep out of reach of children. lf swallowed, get medical help or contact a Poison ControlCenter right away", "51727-6": "WATER BUTYLOCTYL SALICYLATE NEOPENTYL GLYCOL DIHEPTANOATE MICA CI 77891 BUTYL METHOXYDIBENZOYLMETHANE GLYCERIN PROPYLENE GLYCOL VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER CETEARYL ALCOHOL COCO-GLUCOSIDE GLYCERYL STEARATE PEG-100 STEARATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER SILICA POTASSIUM CETYL PHOSPHATE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER CETEARYL ALCOHOL HYDROXYACETOPHENONE PHENOXYETHANOL ETHYLHEXYLGLYCERIN CI 77492 TRIETHOXYCAPRYLYLSILANE DISODIUM EDTA CI 77491 CI 77499", "55105-1": "Sunscreen", "55106-9": "AVOBENZONE G63QQF2NOX 3.0% OCTISALATE 4X49Y0596W 5.0% OCTOCRYLENE 5A68WGF6WM 7.0% HOMOSALATE V06SV4M95S 9%"}