Label: MARIO BADESCU THE MOISTURE MAGNET SPF 15- avobenzone, octinoxate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 54111-138-50 - Packager: Bentley Laboratories LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 20, 2018
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Warnings
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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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 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), Butylene Glycol, Sesamum Indicum (Sesame) Seed Oil, Saccharide Isomerate, Paraffinum Liquidum (Mineral Oil, Huile Minérale), Ethylhexyl Methoxycrylene, Glyceryl Isostearate, Cetearyl Alcohol, Tocopherol Acetate, Stearic Acid, Dimethicone, Glycerin, C10-30 Cholesterol/Lanosterol Esters, Gardenia Florida Fruit Extract, Ethylhexylglycerin, Ceteareth-20, Carbomer, Phenoxyethanol, Sodium Hydroxide, CI 17200 (Red 33), CI 60730 (Ext. Violet 2), CI 42090 (Blue 1)
- STORAGE AND HANDLING
- QUESTIONS
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Principal Display Panel
MARIO
BADESCU
SKIN CARE
Established 1967
MBTHE MOISTURE
MAGNET
BROAD SPECTRUM
SPF 15 SUNSCREEN2 fl oz ℮ (59 ml)
SKIN
TYPES
C,D,SHelp protect skin from harmful UVA/UVB rays that can prematurely age skin with this hydrating moisturizer with broad spectrum protection. Specially designed for mature skin types.
Made in USA. 03102-J002
CRUELTY FREE | PARABEN FREE
Mario Badescu Skin Care, New York, NY • (800) BADESCU
Leceur Plaza 1 Salford M50 3UB, UK
order online at mariobadescu.comDrug Facts
Active ingredients Purpose
Avobenzone 3%, Octinoxate 7.5%,
Oxybenzone 5% , . . . . . . . . . . . . . . . . . . . SuncreenFOR DRUG FACTS LIFT HERE
Drug Facts (continued)
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
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.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.Directions
• apply liberally 15 minutes before sun exposure • use a water-resistant sunscreen if swimming or sweating • reapply at least every 2Drug Facts (continued)
hours • 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 ingredients Aqua (Water, Eau), Butylene Glycol, Sesamum Indicum (Sesame) Seed Oil, Saccharide Isomerate, Paraffinum Liquidum (Mineral Oil, Huile Minérale), Ethylhexyl Methoxycrylene, Glyceryl Isostearate, Cetearyl Alcohol, Tocopherol Acetate, Stearic Acid, Dimethicone, Glycerin, C10-30 Cholesterol/Lanosterol Esters, Gardenia Florida Fruit Extract, Ethylhexylglycerin, Ceteareth-20, Carbomer, Phenoxyethanol, Sodium Hydroxide, CI 17200 (Red 33), CI 60730 (Ext. Violet 2), CI 42090 (Blue 1)
Other information Protect this product from excessive heat and direct sun.
Questions or comments? Call 1-800-223-3728 M – F 9 a.m. – 5 p.m. EST or visit mariobadescu.com
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INGREDIENTS AND APPEARANCE
MARIO BADESCU THE MOISTURE MAGNET SPF 15
avobenzone, octinoxate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-138 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.77 g in 59 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4.425 g in 59 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.95 g in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SESAME OIL (UNII: QX10HYY4QV) SACCHARIDE ISOMERATE (UNII: W8K377W98I) MINERAL OIL (UNII: T5L8T28FGP) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STEARIC ACID (UNII: 4ELV7Z65AP) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y) GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) D&C RED NO. 33 (UNII: 9DBA0SBB0L) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54111-138-50 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/13/2017 Labeler - Bentley Laboratories LLC (068351753)