Mario Badescu

Mario Badescu
SPL v1
SPL
SPL Set ID 782a8641-7e6a-413b-a2ed-0efeb36c48a7
Route
TOPICAL
Published
Effective Date 2024-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (12.025 g)
Inactive Ingredients
Water Isododecane Caprylyl Trisiloxane Propanediol Coco-caprylate/caprate Glycerin Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Methyl Dihydroabietate Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Starch, Corn Dimethicone Sodium Chloride Physalis Pubescens Fruit Juice Yeast, Unspecified Hyaluronic Acid Lycium Chinense Fruit Lowbush Blueberry Cranberry Tocopherol Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Polyglyceryl-3 Pentaricinoleate Phenoxyethanol Disteardimonium Hectorite Zinc Stearate 1,2-hexanediol Caprylyl Glycol Medium-chain Triglycerides Isostearic Acid Propylene Carbonate Sodium Gluconate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-15

Description

Drug Facts Active ingredient Zinc Oxide 12.025%


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and 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.

Description

Drug Facts Active ingredient Zinc Oxide 12.025%

Section 50565-1

Keep out of reach of children.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6

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

Section 53413-1

Questions or comments? Call 1-800-223-3728

M – F 9 a.m. – 5 p.m. EST or visit mariobadescu.com

Section 55105-1

Purpose 

Sunscreen

Section 55106-9

Drug Facts

Active ingredient

Zinc Oxide 12.025%

Section 60561-8

Other information Protect this product from

excessive heat and direct sun.

Mario Badescu Mineral Sunscreen Spf 30

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



res


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-223-3728

M – F 9 a.m. – 5 p.m. EST or visit mariobadescu.com

Section 55105-1 (55105-1)

Purpose 

Sunscreen

Section 55106-9 (55106-9)

Drug Facts

Active ingredient

Zinc Oxide 12.025%

Section 60561-8 (60561-8)

Other information Protect this product from

excessive heat and direct sun.

Mario Badescu Mineral Sunscreen Spf 30 (Mario Badescu Mineral Sunscreen SPF 30)

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



res


Advanced Ingredient Data


Raw Label Data

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