Otc - Active Ingredient
Drug Facts
Active ingredient
Zinc Oxide 12.025%
Mineral Sunscreen Cream
FDA Label NDC 54111-183
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bentley Laboratories Llc for the product Mineral Sunscreen (NDC 54111-183). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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.
Otc - 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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