SPL v1
SPL
SPL Set ID 28c2795d-0351-13c8-e063-6394a90a56d7
Route
TOPICAL
Published
Effective Date 2024-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-09

Description

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


Medication Information

Warnings and Precautions



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

Indications and Usage



Uses

Helps prevent sunburn.lf used as directed with other sun protection measures (see Directions), decreases therisk of skin cancer and early skin aging causedby the sun.

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



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



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.

Section 50570-1



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 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)



Uses

Helps prevent sunburn.lf used as directed with other sun protection measures (see Directions), decreases therisk of skin cancer and early skin aging causedby the sun.

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 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 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)



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)



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.

Section 50570-1 (50570-1)



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 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


Raw Label Data

All Sections (JSON)