MINERAL SUNSCREEN- zinc oxide sunscreen cream

Mineral Sunscreen by

Drug Labeling and Warnings

Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredient

Zinc Oxide 12.025%

PURPOSE

Purpose 

Sunscreen

INDICATIONS & USAGE

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

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

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.

QUESTIONS

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

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

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INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN 
zinc oxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-183
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12.025 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PROPANEDIOL (UNII: 5965N8W85T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
STARCH, CORN (UNII: O8232NY3SJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHYSALIS PUBESCENS FRUIT JUICE (UNII: GM2TDN9DZI)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
HYALURONIC ACID (UNII: S270N0TRQY)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
CRANBERRY (UNII: 0MVO31Q3QS)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ZINC STEARATE (UNII: H92E6QA4FV)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOSTEARIC ACID (UNII: X33R8U0062)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-183-01	1 in 1 CARTON	12/15/2020
1		42 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	12/15/2020

Labeler - Bentley Laboratories LLC (068351753)