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

UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredietns

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 butyloctyl salicylate dextrin palmitate butylene glycol triacontanyl pvp hydrogenated lecithin sodium hyaluronate tocopherol algae extract litchi chinensis seed extract oryzanol biosaccharide gum-1 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 citric acid xanthan gum acrylates/dimethicone copolymer dextrin tocopheryl acetate disodium edta phenoxyethanol sodium benzoate [iln54365]

Other information

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

PRINCIPAL DISPLAY PANEL

CLINIQUE
UV solutions
hydrating
SPF 50
BROAD SPECTRUM SPF 50
SUNSCREEN
HYALURONIC ACID+ ANTIOXIDANTS
1.4 FL.OZ.LIQ./40 ml e

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-224
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
TOCOPHEROL (UNII: R0ZB2556P8)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
TRIACONTANYL PVP (UNII: N0SS3Q238D)
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
ICODEXTRIN (UNII: 2NX48Z0A9G)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ORYZANOL (UNII: SST9XCL51M)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICA (UNII: ETJ7Z6XBU4)
ISODODECANE (UNII: A8289P68Y2)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-224-01	1 in 1 CARTON	02/01/2026
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49527-224-02	1 in 1 CARTON	02/01/2026
2		5 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	02/01/2026

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(49527-224) , label(49527-224) , pack(49527-224)