ESSENCE LIGHT SUNSCREEN SPF 50 PA- avobenzone, homosalate, octisalate, octocrylene lotion

ESSENCE LIGHT SUNSCREEN SPF 50 PA by

Drug Labeling and Warnings

ESSENCE LIGHT SUNSCREEN SPF 50 PA by is a Otc medication manufactured, distributed, or labeled by ENGLEWOOD LAB, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

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.

Do not use

on damaged or broken skin

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.

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.

Other information

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

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

INGREDIENTS AND APPEARANCE

ESSENCE LIGHT SUNSCREEN SPF 50 PA 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14268-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONIC ACID (UNII: S270N0TRQY)
ASIAN GINSENG (UNII: CUQ3A77YXI)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
PANTHENOL (UNII: WV9CM0O67Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOHEXADECANE (UNII: 918X1OUF1E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
OCTYLDODECANOL (UNII: 461N1O614Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14268-119-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2023
2	NDC: 14268-119-10	10 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2023

Labeler - ENGLEWOOD LAB, INC. (172198223)