UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS- titanium dioxide and zinc oxide cream

UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS by

Drug Labeling and Warnings

UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS 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

TITANIUM DIOXIDE 3.8%
ZINC OXIDE 20.7%

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

Directions

For sunscreen use:
apply liberally 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,dicaprylyl ether,isododecane,butyloctyl salicylate,dimethicone/vinyl dimethicone crosspolymer,niacinamide,polyglyceryl-3 diisostearate,isononyl isononanoate,diethylhexyl succinate,cetyl peg/ppg-10/1 dimethicone,lauryl peg-9 polydimethylsiloxyethyl dimethicone,butylene glycol,diphenylsiloxy phenyl trimethicone,silica,polyhydroxystearic acid,sodium chloride,caprylic/capric triglyceride,trimethylsiloxysilicate,sodium hyaluronate,litchi chinensis seed extract,caffeine,oryzanol,dimethicone,c12-15 alkyl benzoate,caprylyl glycol,polyglyceryl-3 polyricinoleate,biosaccharide gum-1,7-dehydrocholesterol,disteardimonium hectorite,dimethicone silylate,lecithin,propylene carbonate,xanthan gum,potassium hydroxide,isostearic acid,dextrin,triethoxycaprylylsilane,tocopherol,disodium edta,phenoxyethanol,iron oxides (ci 77492),iron oxides (ci 77491) [iln54848]

Other information

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

PDP

CLINIQUE
UV solutions
brightening + tinted

BROAD SPECTRUM SPF 50

SUNSCREEN

NIACINAMIDE + ANTIOXIDANTS

1.4 FL. OZ.LIQ/40ml

INGREDIENTS AND APPEARANCE

UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-227
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	207 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	38 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
XANTHAN GUM (UNII: TTV12P4NEE)
ISOSTEARIC ACID (UNII: X33R8U0062)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
TOCOPHEROL (UNII: R0ZB2556P8)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ORYZANOL (UNII: SST9XCL51M)
NIACINAMIDE (UNII: 25X51I8RD4)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
WATER (UNII: 059QF0KO0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ICODEXTRIN (UNII: 2NX48Z0A9G)
ISODODECANE (UNII: A8289P68Y2)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICA (UNII: ETJ7Z6XBU4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
CAFFEINE (UNII: 3G6A5W338E)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-227-01	1 in 1 CARTON	09/01/2025
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	09/01/2025

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	label(49527-227) , pack(49527-227) , manufacture(49527-227)