SPL v3
SPL
SPL Set ID 28ed3b60-1139-f657-e063-6394a90a52fa
Route
TOPICAL
Published
Effective Date 2024-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (4.5 g) Octocrylene (3.5 g) Avobenzone (1.5 g) Octisalate (2.5 g)
Inactive Ingredients
Peg-100 Stearate Butyloctyl Salicylate Ci 77491 Phenoxyethanol Triethoxycaprylylsilane Edetate Disodium Ammonium Acryloyldimethyltaurate/vp Copolymer Cetearyl Alcohol Coco Glucoside Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Ci 77499 Ci 77492 Hydroxyacetophenone Ethylhexylglycerin Mica Ci 77891 Silica Glyceryl Stearate Potassium Cetyl Phosphate Glycerin Neopentyl Glycol Diheptanoate Propylene Glycol Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-12-14 Until 2026-12-19

Description

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

Purpose

Sunscreen


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.

Purpose

Sunscreen

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 50566-9

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.

Section 50567-7



For external use only. Do not use on damagedor broken skin.

When using this product keep out of eyes.nse 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 50570-1



When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

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

Active Ingredient



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 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)



For external use only. Do not use on damagedor broken skin.

When using this product keep out of eyes.nse 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 50570-1 (50570-1)



When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

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)

Purpose (purpose)

Sunscreen

Active Ingredient (active ingredient)



AVOBENZONE G63QQF2NOX 3.0%

OCTISALATE 4X49Y0596W 5.0%

OCTOCRYLENE 5A68WGF6WM 7.0%

HOMOSALATE V06SV4M95S 9%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)