SPL v1
SPL
SPL Set ID 2c9d4943-2be7-8dfd-e063-6394a90a0863
Route
TOPICAL
Published
Effective Date 2025-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (14.4 mg) Glycerin (10.9 mg) Octocrylene (9 mg) Avobenzone (5.4 mg) Octisalate (7.2 mg)
Inactive Ingredients
Propylene Glycol Glyceryl Stearate Phenoxyethanol Edetate Disodium Aluminum Starch Octenylsuccinate Water Glycereth-20 Triethanolamine Chlorphenesin Xanthan Gum Butyloctyl Salicylate Isosteareth-20 Isoceteth-20 Lauric Acid Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s)

Identifiers & Packaging

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

Description

HOMOSALATE GLYCERIN OCTOCRYLENE OCTISALATE AVOBENZONE


Medication Information

Dosage and Administration

Directions: Apply liberaly 15 minues before sunexposure, e Reapply: After 80 minutes of swimming or seating,. lmmedabely after touel drying.. At leastevery 2 hours,

Description

HOMOSALATE GLYCERIN OCTOCRYLENE OCTISALATE AVOBENZONE

When

Apply liberaly 15 minues before sunexposure,

Reapply: After 80 minutes of swimming orsseating,

lmmedabely after touel drying.. At leastevery 2 hours,

Section 50565-1

keep out of children to use it

Section 55105-1

Helps prevent sunbum, if used as directed withother sun protection measures (see Direciions), decreasesthe risk of skin cancer and eary aging caused by the sun

Warning



For extemal use onl,.

Do not use on damaged or broken skn,

When using this product keep out of cyes, Rinse withwater to remowe,

Siop use and ask a doctor if rash cccurs.Keep out of reach of children, lf product is swalkawed, getmedical help or contact a Potson Conirol Centre right away.Wlay stain some fabrics.

Labeling

Do Not Use

Do not use on damaged or broken skn

Indication

Directions: Apply liberaly 15 minues before sunexposure,

Reapply: After 80 minutes of swimming or sseating,

lmmedabely after towel drying.

At least every 2 hours,

Children under 6 months: Ask a Doctor

Sun Protection Measures: spendng time in the suni ncreases your risk of skin caner and early skin aging.

To decrease this risk, regulary use a sunsereen with a broad spectrum spf value of 15 or higher and other sun protection measure including, lmit time in the sun,especially from 10a,m. to 2p.m, Wear long-sleeved shirtspanis, hats, and sunglasses,

Stop to Use

Stop use and ask a doctor if rash occurs

Active Ingredient

HOMOSALATE

GLYCERIN

OCTOCRYLENE

OCTISALATE

AVOBENZONE

Inactive Ingredient

PROPYLENE GLYCOL

WATER

BUTYLOCTYL SALICYLATE

GLYCERETH-20

ISOSTEARETH-20

ISOCETETH-20

LAURIC/MYRISTIC/PALMITIC/STEARIC GLYCERIDES

GLYCERYL STEARATE

ALUMINUM STARCH OCTENYLSUCCINATE

PHENOXYETHANOL

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

TRIETHANOLAMINE

CHLORPHENESIN

FRAGRANCE

DISODIUM EDTA

XANTHAN GUM


Structured Label Content

When

Apply liberaly 15 minues before sunexposure,

Reapply: After 80 minutes of swimming orsseating,

lmmedabely after touel drying.. At leastevery 2 hours,

Dosage and Administration (34068-7)

Directions: Apply liberaly 15 minues before sunexposure, e Reapply: After 80 minutes of swimming or seating,. lmmedabely after touel drying.. At leastevery 2 hours,

Section 50565-1 (50565-1)

keep out of children to use it

Section 55105-1 (55105-1)

Helps prevent sunbum, if used as directed withother sun protection measures (see Direciions), decreasesthe risk of skin cancer and eary aging caused by the sun

Warning



For extemal use onl,.

Do not use on damaged or broken skn,

When using this product keep out of cyes, Rinse withwater to remowe,

Siop use and ask a doctor if rash cccurs.Keep out of reach of children, lf product is swalkawed, getmedical help or contact a Potson Conirol Centre right away.Wlay stain some fabrics.

Labeling (labeling)

Do Not Use (Do not use)

Do not use on damaged or broken skn

Indication

Directions: Apply liberaly 15 minues before sunexposure,

Reapply: After 80 minutes of swimming or sseating,

lmmedabely after towel drying.

At least every 2 hours,

Children under 6 months: Ask a Doctor

Sun Protection Measures: spendng time in the suni ncreases your risk of skin caner and early skin aging.

To decrease this risk, regulary use a sunsereen with a broad spectrum spf value of 15 or higher and other sun protection measure including, lmit time in the sun,especially from 10a,m. to 2p.m, Wear long-sleeved shirtspanis, hats, and sunglasses,

Stop to Use (stop to use)

Stop use and ask a doctor if rash occurs

Active Ingredient (Active ingredient)

HOMOSALATE

GLYCERIN

OCTOCRYLENE

OCTISALATE

AVOBENZONE

Inactive Ingredient (Inactive ingredient)

PROPYLENE GLYCOL

WATER

BUTYLOCTYL SALICYLATE

GLYCERETH-20

ISOSTEARETH-20

ISOCETETH-20

LAURIC/MYRISTIC/PALMITIC/STEARIC GLYCERIDES

GLYCERYL STEARATE

ALUMINUM STARCH OCTENYLSUCCINATE

PHENOXYETHANOL

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

TRIETHANOLAMINE

CHLORPHENESIN

FRAGRANCE

DISODIUM EDTA

XANTHAN GUM


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)