UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50- avobenzone,homosalate,octisalate,octocrylene cream

UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., The Estee Lauder Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%
Homosalate 7%
Octisalate 4.5%

Octocrylene 7%

Purpose

Sunscreen

Use

helps prevent sunburn

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

For sunscreen use:
apply liberally and evenly 15 minutes before sun exposure
reapply at least every two hours
use a water resistant sunscreen if swimming or sweating
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.
■ wear long-sleeved shirts, pants, hats and sunglasses
children under 6 months of age: ask a doctor

Inactive Ingredients

water\aqua\eau,glycerin,phenyl trimethicone,silica,dextrin palmitate,butyloctyl salicylate,butylene glycol,triacontanyl pvp,hydrogenated lecithin,tocopherol,sodium hyaluronate,algae extract,litchi chinensis seed extract,salicylic acid,caprylyl glycol,oryzanol,dicetyldimonium chloride,phosphatidylcholine,7-dehydrocholesterol,hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer,ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer,glyceryl stearate,peg-100 stearate,sorbitan isostearate,polysorbate 20,polysorbate 60,isododecane,xanthan gum,acrylates/dimethicone copolymer,dextrin,tocopheryl acetate,disodium edta,phenoxyethanol,sodium benzoate [iln54476]

Other information

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

PRINCIPAL DISPLAY PANEL

CLINIQUE

UV solutoins mattifying

SPF 50

BRAOD SPECTRUM SPF 50
SUNSCREEN
SALICYLIC ACID + ANTIOXIDANTS

1.4 FL.OZ.LIQ./40 ml

INGREDIENTS AND APPEARANCE

UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50 
avobenzone,homosalate,octisalate,octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG-100 STEARATE (UNII: YD01N1999R)
ISODODECANE (UNII: A8289P68Y2)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIACONTANYL PVP (UNII: N0SS3Q238D)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
DEXTRIN, CORN (UNII: VAD2K35XAJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SILICA (UNII: ETJ7Z6XBU4)
GLYCINE MAX (SOYBEAN) OIL (UNII: 241ATL177A)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DICETYLDIMONIUM CHLORIDE (UNII: 6F4SX2007N)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
XANTHAN GUM (UNII: TTV12P4NEE)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
ORYZANOL (UNII: SST9XCL51M)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-226-01	1 in 1 CARTON	01/01/2026
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2026

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(49527-226)