MDSOLARSCIENCES SPF40 ULTRA-SPORT- meradimate and octisalate and octocrylene and titanium dioxide and zinc oxide stick

MDSolarSciences SPF40 Ultra-Sport by

Drug Labeling and Warnings

MDSolarSciences SPF40 Ultra-Sport by is a Otc medication manufactured, distributed, or labeled by Ecometics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Igredients

Meradimate 3.50% .......... Sunscreen

Octisalate 3.50% .......... Sunscreen

Octocrylene 10.00% .......... Sunscreen

Titanium Dioxide 1.35% .......... Sunscreen

Zinc Oxide 10.25% .......... Sunscreen

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

Retains SPF after 80 minutes of activity in the water or sweating

Warnings

For external uses only.

When using this product
keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if
rash or irritation develops and lasts.

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

Other Information

Sun alert: Limiting sun exposure, wearing
protective clothing, and using sunscreen may
reduce the risk of skin aging, skin cancer, and
other harmful effects of the sun.
May stain
clothing.You may report serious adverse
reactions to Report Reactions, LLC,
PO Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

Caprlyl Methicone, Cyclopentasiloxane, Butyrospemum Parkll (Shea Butter), Petrolatum, Beesewax, Polyethylene, C12-15 Alkyl Benzoate, Paraffin Wax, Simmondsia Chinensis (Jojoba) Butter, Copernicia Cerifera (Carnauba) Wax, Polyester-8, Hydrogenated Soybean Oil, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethysiloxyethyl Hexyl Dimethicone, Microcrystalline Wax, BHT, Aluminum Hydroxide, Tetrahexyldecyl Ascorbate

Directions

Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing. Effective sun protection for children under 2 years of age is strongly recommended.

Principle Display Panel

MDSolarSciences
SPF 40
Broad Spectrum
UVA-UVB Sunscreen
Ultra-Sport
Stick
LIGHT and MOISTURIZING
Very Water Resistant
No Fragrance
For Adults and Children
10 g - .35 Oz

Additional Carton Labeling

MDSolarSciences Corp
40 Richards Avenue, 3rd Floor, Norwalk, CT 06854

www.mdsolarsciences.com
Patent Pending

UPC 8 55488 00204 2

INGREDIENTS AND APPEARANCE

MDSOLARSCIENCES SPF40 ULTRA-SPORT 
meradimate and octisalate and octocrylene and titanium dioxide and zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17452-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Meradimate (UNII: J9QGD60OUZ) (Meradimate - UNII:J9QGD60OUZ)	Meradimate	0.35 g  in 10 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.35 g  in 10 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	1 g  in 10 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.135 g  in 10 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.025 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
JOJOBA OIL (UNII: 724GKU717M)
Carnauba Wax (UNII: R12CBM0EIZ)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17452-360-01	10 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2010

Labeler - Ecometics, Inc (064843923)

Registrant - Ecometics, Inc (064843923)

Establishment
Name	Address	ID/FEI	Business Operations
Ecometics, Inc		064843923	manufacture