Mario Badescu Hyaluronic Moisturizer broad Spectrum Spf 15 Sunscreen

Mario Badescu Hyaluronic Moisturizer broad Spectrum Spf 15 Sunscreen
SPL v1
SPL
SPL Set ID 88bd6dff-ba19-4f8f-9432-28398d24f1ab
Route
TOPICAL
Published
Effective Date 2024-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Oxybenzone (5.0 g) Avobenzone (3.0 g)
Inactive Ingredients
Water Dimethicone Butylene Glycol Mineral Oil Sesame Oil Ethylhexyl Methoxycrylene Glyceryl Stearate Se Glyceryl Isostearate Stearic Acid Hyaluronate Sodium C10-30 Cholesterol/lanosterol Esters Ethylhexylglycerin Carbomer Homopolymer, Unspecified Type Phenoxyethanol Sodium Hydroxide Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-01

Description

Drug Facts Active ingredients Avobenzone 3%, Octinoxate 7.5%, Oxybenzone 5%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use on damaged or broken skin.

S top 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 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.

Description

Drug Facts Active ingredients Avobenzone 3%, Octinoxate 7.5%, Oxybenzone 5%

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), 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)

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 ingredients

Avobenzone 3%, Octinoxate 7.5%, Oxybenzone 5%

Section 60561-8

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

Mario Badescu hyaluronic Moisturizer Spf 15

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

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 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.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use on damaged or broken skin.

S top 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), 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)

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 ingredients

Avobenzone 3%, Octinoxate 7.5%, Oxybenzone 5%

Section 60561-8 (60561-8)

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

Mario Badescu hyaluronic Moisturizer Spf 15 (Mario Badescu HYALURONIC MOISTURIZER SPF 15)

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

res


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