MELVITA PROSUN SPF 15 SUN  - titanium dioxide and zinc oxide cream 
Laboratoires M&L

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.

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Melvita PROSUN SPF 15 Sun Cream

Active Ingredients

Titanium Dioxide  5.905%                 
Zinc Oxide           12%                   

Uses

Warnings

For external use only.

When using this product

- Keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if:

- Rash or irritation develops and lasts.

Keep Out Of Reach Of Children

Keep out of the reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally before sun exposure and as needed 

Children under 6 months of age: ask a doctor  - Reapply as needed or after towel drying, swimming or sweating

Other information

Moderate sun protection product  sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Citrus Aurantium Dulcis FruitWater [Citrus Aurantium Dulcis (Orange)FruitWater]*, Caprylic/Capric Triglyceride, Aqua[Water], Helianthus Annuus Seed Oil [Helianthus Annuus (Sunflower) Seed Oil]*, Polyglyceryl-2 polyhydraystearate, Glycerin, Octyldecanol, Silica, Lauryl Laurate, Mangifera Indica Seed Oil [Mangifera Indica (Mango) Seed Butter], Sesamum Indicum Seed Oil [Sesamum Indicum (Sesame) Seed Oil]*, Simmondsia Chinensis Seed Oil [Simmondsia Chinensis (Jojoba) Seed Oil]*, Glyceryl Isostearate, Benzyl Alcohol, Olus Oil (Vegatable Oil), Polyglyceryl-3 Disostearate, Pongamol, Alumina, Stearic Acid, PolyhydroxyStearic Acid, Cera Alba [Beeswax], Magnesium Sulfate, Parfum [Fragrance], Tocopherol, Dehydroacetic Acid, Hydrogenated Vegetable Oil, Inositol, Sodium Phytate, Candelila Cera [Euphorbia Cerifera (Candelilla) Wax], Linalool**, Citronellol**, Limonene**, Alcohol.  * Ingredients from Organic Farming

Description

Packaging from sustainably managed forests and printed with vegetable inks.  SPF 15 sun cream medium protection - darker skin.  This nano-particle free formulation contains natural mineral sun filters to provide medium protection. The cream is recommended for darker skins, offering protection against A-type ultra-violet rays and helping towards a radiant, lasting tan. It is also recommended for moderate sun exposure. It owes its protective, moisturizing properties to the Pongamia extract, Mango butter and Sesame and Jojoba oils. Carob extract intensifies the quality of the tan and helps to sustain it. Usage instructions : apply generously to dry skin on the face and body before and during exposure to the sun. Renew the applications approximately every 2 hours and after swimming or sporting activities. Avoid the eye contour,  Sun advice : Choose your level of sun protection based on your skin type. Avoid exposure between 12.00 and 4.00 pm and do not extend your exposure time. Protect children from the sun' s direct rays and always shelter children under the age of 3.  Sun Protection indicee UVA and SPF calculated by an independent laboratory UVA protection complient with the European SPF/UVA Less than or equal to 3 ratio Critical wavelength Less than or equal to 370 mm 100% mineral origin sun block.  Natural and Organic Cosmetic certified by ECOCERT Greenlife according to ECOCERT Standard available at http://cosmetic.eccocert.com  98.95% of the total ingredients from natural origin. 32% of the total ingredients from Organic Farming.

Purpose

Sunscreen

Melvita PROSUN SPF 15 Sun Cream 75ml (43611-002-00)


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MELVITA PROSUN SPF 15 SUN  
titanium dioxide, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43611-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 59.05 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 120 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ORANGE (UNII: 5EVU04N5QU)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDECANOL (UNII: 07UG7TSU58)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LAURYL LAURATE (UNII: GPW77G0937)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
SESAME OIL (UNII: QX10HYY4QV)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PONGAMOL (UNII: 8Y19QCY6I4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
INOSITOL (UNII: 4L6452S749)  
CANDELILLA WAX (UNII: WL0328HX19)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43611-002-00 1 in 1 BOX
1 75 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/12/2011
Labeler - Laboratoires M&L (263910193)
Registrant - Laboratoires M&L (263910193)
Establishment
Name Address ID/FEI Business Operations
Laboratoires M&L 263910193 manufacture(43611-002)

Revised: 4/2013
Document Id: b34d0ae5-bda0-48eb-94cc-3caa57f68c2a
Set id: 571e9310-c606-4ecb-aad8-5eff272303e1
Version: 4
Effective Time: 20130424
 
Laboratoires M&L