Mineral Sunscreen

Manufacturer
Bentley Laboratories LLC
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:26:21

Label at a glance#

ProductMineral Sunscreen
Active ingredientZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient

Zinc Oxide 12.025%

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

WarningsFor 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 evenly to the face as the last step of
your skin care routine and 15 minutes before sun exposure.
Can be used under makeup. Reapply at least every two
hours, especially after swimming or sweating. • Children
under 6 months: 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. • Wear
long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT SECTION

Inactive ingredients Aqua (Water, Eau),
Isododecane, Caprylyl Methicone, Propanediol,
Coco-Caprylate / Caprate, Glycerin, Cetyl PEG / PPG-10 / 1
Dimethicone, Methyl Dihydroabietate, Polyglyceryl-4
Diisostearate/Polyhydroxystearate/Sebacate, Zea Mays
(Corn) Starch, Dimethicone, Sodium Chloride, Physalis
Pubescens Fruit Juice, Yeast Extract, Hyaluronic Acid, Lycium
Chinense Fruit Extract, Vaccinium Angustifolium (Blueberry)
Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit
Extract, Tocopherol, Pentaerythrityl Tetra-di-t-butyl
Hydroxyhydrocinnamate, Polyglyceryl-3 Polyricinoleate,
Phenoxyethanol, Disteardimonium Hectorite, Zinc Stearate,
1,2-Hexanediol, Caprylyl Glycol, Caprylic/Capric Triglyceride,
Isostearic Acid, Propylene Carbonate, Sodium Gluconate

OTHER SAFETY INFORMATION

Other informationProtect 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 Mineral Sunscreen SPF 30 product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MARIO
BADESCU
SKIN CARE
Since 1967
MB

MINERAL

SUNSCREEN

BROAD SPECTRUM

SPF 30 SUNSCREEN

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

54111-183 Crtn54111-183 Crtn

54111-183 Inner54111-183 Inner


res

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-183-01Mineral Sunscreen1 in 1 CARTONCREAM11
54111-183-01Mineral Sunscreen42 mL in 1 TUBECREAM421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-183MINERAL SUNSCREEN (ZINC OXIDE SUNSCREEN) CREAM [BENTLEY LABORATORIES LLC]1Current NDC, 2 package rows20241018_782a8641-7e6a-413b-a2ed-0efeb36c48a7.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-18354111-183-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

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
Mineral SunscreenZINC OXIDE SUNSCREENBentley Laboratories LLC782a8641-7e6a-413b-a2ed-0efeb36c48a72024-10-15WarningsExact identifier
ndc (package): 54111-183-01
ndc (product): 54111-183
ndc11 (package): 54111018301
spl id: 8fbbcad3-e255-4f2a-9902-00f6316a253c
spl set id: 782a8641-7e6a-413b-a2ed-0efeb36c48a7

Reported adverse events (FAERS/openFDA)#

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