SPL v1
SPL
SPL Set ID 2c9e4b53-18cf-d76c-e063-6394a90a4043
Route
TOPICAL
Published
Effective Date 2025-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (18 mg) Avobenzone (5.4 mg) Octisalate (7.2 mg) Octocrylene
Inactive Ingredients
Water Chlorphenesin Steareth-21 Triethanolamine Propylene Glycol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Edetate Disodium C14-22 Alcohols Butyloctyl Salicylate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Dipotassium Glycyrrhizate Alpha-tocopherol Acetate Simmondsia Chinensis (jojoba) Seed Oil Trehalose Silica Phenoxyethanol C12-20 Alkyl Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-26

Description

HOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONE

Purpose

Helps prevent sunbum, if used as directed withoWer sun 0rotacton measures isee Dirccans. 0ecreasethe risk of skin cancer and early aging caused by the sun,


Medication Information

Warnings and Precautions

For extemal use only.Do not use on damaged or broken skin.When using this product keep out of eyes, hinse withwater to remoNe,Siop use and ask a doctor if rash cccurs,Keap out of reach of children, lf product is swallowed, getnedical help or conlact a Potson Control Cenire right away

Indications and Usage

Directions: * Apply liberaly 15 minutes before sunexposure, e Reapply: After 80 minutes of swimming orsweating, " |mmedately afler towel drying," At leastevery 2 hours, * Children under 6 months: Ask a docior. Sun Protection Measures:Spending time in the sunincreases your risk of skin canoer and carly skin aging, Todecrease this risk, regulary use a sunscreen with a broadsoectrum spf value of 15 or higher and other sunprotection measure including, lmit time in the sun,especially from 10a.m, to 2p.m, Wear long-sleeved shirtspants, hats, and sunglasses,

Purpose

Helps prevent sunbum, if used as directed withoWer sun 0rotacton measures isee Dirccans. 0ecreasethe risk of skin cancer and early aging caused by the sun,

Dosage and Administration

Directions: * Apply liberaly 15 minutes before sunexposure, e Reapply: After 80 minutes of swimming orsweating, " |mmedately afler towel drying," At leastevery 2 hours, * Children under 6 months: Ask a docior. Sun Protection Measures: $pending time in the sunincreases your risk of skin canoer and carly skin aging, Todecrease this risk, regulary use a sunscreen with a broadsoectrum spf value of 15 or higher and other sunprotection measure including, lmit time in the sun,especially from 10a.m, to 2p.m, Wear long-sleeved shirtspants, hats, and sunglasses,

Description

HOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONE

Active

HOMOSALATE

OCTOCRYLENE

OCTISALATE

AVOBENZONE

Section 50565-1

Keap out of reach of children, lf product is swallowed, getnedical help or conlact a Potson Control Cenire right away

Section 50566-9

Stop use and ask a doctor if rash cccurs,

Section 50567-7

Apply liberaly 15 minutes before su:xposure, * Reapply: After 80 minutes of swimming cely alfler towel drying. At leas!weating.e lmivery 2 hours, * Children under 6 months: Ask a dock

Section 51727-6

PROPYLENE GLYCOL

WATER

C14-22 ALCOHOLS

C12-20 ALKYL GLUCOSIDE

BUTYLOCTYL SALICYLATE

STEARETH-21

TREHALOSE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

PHENOXYETHANOL

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

TRIETHANOLAMINE

CHLORPHENESIN

DIPOTASSIUM GLYCYRRHIZATE

FRAGRANCE

DISODIUM EDTA

TOCOPHERYL ACETATE

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

Section 51945-4

Do Not Use

Do not use on damaged or broken skin.


Structured Label Content

Active (active)

HOMOSALATE

OCTOCRYLENE

OCTISALATE

AVOBENZONE

Indications and Usage (34067-9)

Directions: * Apply liberaly 15 minutes before sunexposure, e Reapply: After 80 minutes of swimming orsweating, " |mmedately afler towel drying," At leastevery 2 hours, * Children under 6 months: Ask a docior. Sun Protection Measures:Spending time in the sunincreases your risk of skin canoer and carly skin aging, Todecrease this risk, regulary use a sunscreen with a broadsoectrum spf value of 15 or higher and other sunprotection measure including, lmit time in the sun,especially from 10a.m, to 2p.m, Wear long-sleeved shirtspants, hats, and sunglasses,

Dosage and Administration (34068-7)

Directions: * Apply liberaly 15 minutes before sunexposure, e Reapply: After 80 minutes of swimming orsweating, " |mmedately afler towel drying," At leastevery 2 hours, * Children under 6 months: Ask a docior. Sun Protection Measures: $pending time in the sunincreases your risk of skin canoer and carly skin aging, Todecrease this risk, regulary use a sunscreen with a broadsoectrum spf value of 15 or higher and other sunprotection measure including, lmit time in the sun,especially from 10a.m, to 2p.m, Wear long-sleeved shirtspants, hats, and sunglasses,

Warnings and Precautions (34071-1)

For extemal use only.Do not use on damaged or broken skin.When using this product keep out of eyes, hinse withwater to remoNe,Siop use and ask a doctor if rash cccurs,Keap out of reach of children, lf product is swallowed, getnedical help or conlact a Potson Control Cenire right away

Section 50565-1 (50565-1)

Keap out of reach of children, lf product is swallowed, getnedical help or conlact a Potson Control Cenire right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash cccurs,

Section 50567-7 (50567-7)

Apply liberaly 15 minutes before su:xposure, * Reapply: After 80 minutes of swimming cely alfler towel drying. At leas!weating.e lmivery 2 hours, * Children under 6 months: Ask a dock

Section 51727-6 (51727-6)

PROPYLENE GLYCOL

WATER

C14-22 ALCOHOLS

C12-20 ALKYL GLUCOSIDE

BUTYLOCTYL SALICYLATE

STEARETH-21

TREHALOSE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

PHENOXYETHANOL

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

TRIETHANOLAMINE

CHLORPHENESIN

DIPOTASSIUM GLYCYRRHIZATE

FRAGRANCE

DISODIUM EDTA

TOCOPHERYL ACETATE

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

Section 51945-4 (51945-4)

Purpose

Helps prevent sunbum, if used as directed withoWer sun 0rotacton measures isee Dirccans. 0ecreasethe risk of skin cancer and early aging caused by the sun,

Do Not Use (do not use)

Do not use on damaged or broken skin.


Advanced Ingredient Data


Raw Label Data

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