FDA.reportPublic FDA data

Hyaluronic Moisturizer

Manufacturer
Bentley Laboratories LLC
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:27:06

Label at a glance#

ProductHyaluronic Moisturizer
Active ingredientOCTINOXATE, OXYBENZONE, AVOBENZONE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients

Avobenzone 3%, Octinoxate 7.5%, Oxybenzone 5%

OTC - PURPOSE SECTION

Purpose 

Sunscreen

INDICATIONS & USAGE SECTION

Uses ● helps prevent sunburn
● If used as directed with other sun protection measures (see Directions),

decreases the risk of skin cancer and early aging caused by the sun.

WARNINGS SECTION

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

• When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions
•apply liberally 15 minutes before sun exposure • use a water-resistant sunscreen if swimming or sweating •reapply at least every 2 hours
• children under 6 months: Ask a doctor •Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early  aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measur es including:
• limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Aqua (Water, Eau), Dimethicone, Butylene Glycol, Paraffinum Liquidum (Mineralil, Huile Minerale)
Sesamum Indicum (Sesame) Seed Oil, Ethylhexyl Methoxycrylene, Glyceryl Stearate SE, Glyceryl Isostearate, Stearic Acid, Sodium
Hyaluronate, C 10-30 Cholesterol/Lanosterol Esters, Ethylhexylglycerin, Parfum (Fragrance), Carbomer, Phenoxyethanol, Sodium Hydroxide, Yellow 5 (CI 19140)

OTHER SAFETY INFORMATION

Other information  Protect this product from excessive heat and direct sun,

OTC - QUESTIONS SECTION

Questions or comments?Call 1-800-223-3728 M – F 9 a.m. – 5 p.m. EST or visit mariobadescu.com

Mario Badescu HYALURONIC MOISTURIZER SPF 15 product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MARIO
BADESCU
SKIN CARE
Established 1967
MB

HYALURONIC MOISTURIZER

Store in a cool, dry place. 0001
Manufactured in the US with
globally-sourced ingredients.
Mario Badescu Skin Care,
New York, NY • (800) BADESCU
Leceur, Bulevardi 21, 00180
Helsinki FI / Plaza 1, Salford
M50 3UB, UK


order online at
mariobadescu.com

54111-182 Botl54111-182 Botl

54111-182 Botl54111-182 Botl

res

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-182-01Hyaluronic Moisturizer59 mL in 1 BOTTLECREAM591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-182HYALURONIC MOISTURIZER (OCTINOXATE, OXYBENZONE. AVOBENZONE) CREAM [BENTLEY LABORATORIES LLC]1Current NDC, 1 package rows20241019_88bd6dff-ba19-4f8f-9432-28398d24f1ab.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-18254111-182-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MINERAL OILT5L8T28FGPIACT
SESAME OILQX10HYY4QVIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
STEARIC ACID4ELV7Z65APIACT
HYALURONATE SODIUMYSE9PPT4THIACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERS137SL7IL0YIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyaluronic MoisturizerOCTINOXATE, OXYBENZONE. AVOBENZONEBentley Laboratories LLC88bd6dff-ba19-4f8f-9432-28398d24f1ab2024-10-16WarningsExact identifier
ndc (package): 54111-182-01
ndc (product): 54111-182
ndc11 (package): 54111018201
spl id: 075fb173-4ec4-47e7-b473-3dffc2df5b0a
spl set id: 88bd6dff-ba19-4f8f-9432-28398d24f1ab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.