Medication Guide App

MDSolarSciences SPF40 Ultra-Sport

Dosage form: stick
Ingredients: Meradimate 0.35g in 10g, Octisalate 0.35g in 10g, Octocrylene 1g in 10g, Titanium Dioxide 0.135g in 10g, Zinc Oxide 1.025g in 10g
Labeler: Ecometics, Inc
NDC Code: 17452-360

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 Facts

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

MDSOLARSCIENCES SPF40 ULTRA-SPORT 
meradimate and octisalate and octocrylene and titanium dioxide and zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17452-360
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Meradimate (Meradimate) Meradimate0.35 g  in 10 g
Octisalate (Octisalate) Octisalate0.35 g  in 10 g
Octocrylene (Octocrylene) Octocrylene1 g  in 10 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide0.135 g  in 10 g
Zinc Oxide (Zinc Oxide) Zinc Oxide1.025 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER 
PETROLATUM 
YELLOW WAX 
C12-15 ALKYL BENZOATE 
JOJOBA OIL 
Carnauba Wax 
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) 
BUTYLATED HYDROXYTOLUENE 
TETRAHEXYLDECYL ASCORBATE 
Packaging
#Item CodePackage Description
1NDC:17452-360-0110 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2010
Labeler - Ecometics, Inc (064843923)
Registrant - Ecometics, Inc (064843923)
Establishment
NameAddressID/FEIOperations
Ecometics, Inc064843923manufacture

Revised: 10/2010
 
Ecometics, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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