Essence Light Sunscreen Spf 50 Pa +++

Essence Light Sunscreen Spf 50 Pa +++
SPL v8
SPL
SPL Set ID f5c79f1a-cecd-2409-e053-2995a90ad06f
Route
TOPICAL
Published
Effective Date 2024-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (90 mg) Octisalate (45 mg) Octocrylene (50 mg)
Inactive Ingredients
Water Dipropylene Glycol Propylene Glycol Butyloctyl Salicylate Polyoxyl 20 Cetostearyl Ether Ethylhexyl Methoxycrylene Ceramide Np Sodium Acetylated Hyaluronate Hyaluronic Acid Asian Ginseng Sorbitan Monooleate Polysorbate 60 Sorbitan Monostearate Caprylyl Glycol Cetearyl Olivate Panthenol Hyaluronate Sodium Glycerin Sorbitan Olivate Tromethamine Isohexadecane 1,2-hexanediol Butylated Hydroxytoluene Ethylhexylglycerin Polysorbate 80 Trisodium Ethylenediamine Disuccinate Xanthan Gum Butylene Glycol Medium-chain Triglycerides Potassium Sorbate Sodium Benzoate Octyldodecanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01

Description

AVOBENZONE 3.0% HOMOSALATE 9.0% OCTISALATE 4.5% OCTOCRYLENE 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 3.0% HOMOSALATE 9.0% OCTISALATE 4.5% OCTOCRYLENE 5.0%

Uses
  • Helps prevent sunburn
  • if used as directed with other sun protection measures (see  Directions), decreases the risk of skin cancer and early skin aging caused by the sun. 
Warnings
  • For external use only.
Directions
  • Apply liberally and evenly 15 minutes before sun exposure 
  • Reapply at least every 2 hours 
  • Use a water-resistant sunscreen if swimming or sweating: 
  • Immediately after towel drying 
  • At least every 2 hours 
  • Children under 6 months of age: Ask a doctor 
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 
  • Limit time in the sun, especially from 10 a.m.– 2 p.m.
Do Not Use

on damaged or broken skin

Other Information

• Protect the product in this container from excessive heat and direct sun

Active Ingredients

AVOBENZONE 3.0%

HOMOSALATE 9.0%

OCTISALATE 4.5%

OCTOCRYLENE 5.0%

Inactive Ingredients

WATER (AQUA), DIPROPYLENE GLYCOL, METHYL METHACRYLA CROSSPOLYMER, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CETEARETH-20, ETHYLHEXYL METHOXYCRYLENE, ACRYLATES COPOLYMER, GALACTOMYCES FERMENT FILTRATE, SACCHAROMYCES FERMENT FILTRATE, CERAMIDE NP, HYDROLYZED HYALURONIC ACID, SODIUM ACETYLATED HYALURONATE, HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, POTASSIUM HYALURONATE, PANAX GINSENG ROOT EXTRACT, SORBITAN OLEATE, POLYSORBATE 60, SORBITAN STEARATE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, PANTHENOL, SODIUM HYALURONATE, GLYCERIN, SORBITAN OLIVATE, ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER, TROMETHAMINE, SODIUM ACRYLATE/ SODIUM ACRYLOYLDIMETHYL TAURATECOPOLYMER, ISOHEXADECANE, AMMONIUM ACRYLOYLMETHYLTAURATE/ VP COPOLYMER, 1,2-HEXANEDIOL,BHT,ETHYLHEXYLGLYCERIN, POLYSORBATE 80, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, XANTHAN GUM, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROXYPROPY-LTRIMONIUM HYALURONATE, POTASSIUM SORBATE, HYDROGENATED LECITHIN, SODIUMBENZOATE, OCTYLDODECANOL

Package Labeling:10ml

Package Labeling:50ml

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • Helps prevent sunburn
  • if used as directed with other sun protection measures (see  Directions), decreases the risk of skin cancer and early skin aging caused by the sun. 
Purpose

Sunscreen

Warnings
  • For external use only.
Directions
  • Apply liberally and evenly 15 minutes before sun exposure 
  • Reapply at least every 2 hours 
  • Use a water-resistant sunscreen if swimming or sweating: 
  • Immediately after towel drying 
  • At least every 2 hours 
  • Children under 6 months of age: Ask a doctor 
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 
  • Limit time in the sun, especially from 10 a.m.– 2 p.m.
Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

• Protect the product in this container from excessive heat and direct sun

Active Ingredients

AVOBENZONE 3.0%

HOMOSALATE 9.0%

OCTISALATE 4.5%

OCTOCRYLENE 5.0%

Inactive Ingredients

WATER (AQUA), DIPROPYLENE GLYCOL, METHYL METHACRYLA CROSSPOLYMER, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CETEARETH-20, ETHYLHEXYL METHOXYCRYLENE, ACRYLATES COPOLYMER, GALACTOMYCES FERMENT FILTRATE, SACCHAROMYCES FERMENT FILTRATE, CERAMIDE NP, HYDROLYZED HYALURONIC ACID, SODIUM ACETYLATED HYALURONATE, HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, POTASSIUM HYALURONATE, PANAX GINSENG ROOT EXTRACT, SORBITAN OLEATE, POLYSORBATE 60, SORBITAN STEARATE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, PANTHENOL, SODIUM HYALURONATE, GLYCERIN, SORBITAN OLIVATE, ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER, TROMETHAMINE, SODIUM ACRYLATE/ SODIUM ACRYLOYLDIMETHYL TAURATECOPOLYMER, ISOHEXADECANE, AMMONIUM ACRYLOYLMETHYLTAURATE/ VP COPOLYMER, 1,2-HEXANEDIOL,BHT,ETHYLHEXYLGLYCERIN, POLYSORBATE 80, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, XANTHAN GUM, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROXYPROPY-LTRIMONIUM HYALURONATE, POTASSIUM SORBATE, HYDROGENATED LECITHIN, SODIUMBENZOATE, OCTYLDODECANOL

Package Labeling:10ml

Package Labeling:50ml

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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