Sun Total Protector Color 30 Light Tint

Dosage form: cream
Ingredients: Zinc Oxide 7.8mL in 100mL, Octisalate 4mL in 100mL, Octinoxate 7.5mL in 100mL
Labeler: MD Formulations
NDC Code: 66078-503

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.

Total Protector Color 30 light tint

Zinc Oxide - 7.8%
Octlnoxate - 7.5%
Octlsolote  - 4.0%

Zinc Oxide - 7.8%   Sunscreen
Octlnoxate - 7.5%   Sunscreen
Octlsolote  - 4.0%   Sunscreen

When using this product do not use in or near the eyes. If product gets into eyes, rinse thoroughly with water.

Uses to help prevent sunburn and for the temporary protection of sunburn.

Warnings : For external use only.

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

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

Children under 2 years of age should use sunscreen products with a minimum SPF of 4. Adults and children 6 months and over; apply liberally 15 minutes before sun or water exposure; reapply after swimming or excessive sweating or anytime after towel drying. Children under 6 months ask a doctor.

Other information Store at 20-25C (68 - 77F) Sun Alert: The sun causes sun damage. Regular use of sunscreens over the years may reduce the chance of skin damage, some types of skin cancer, and other harmful effects due to the sun.

Inactive ingredients: Water (Aqua), C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Stearelh·2, Stearelh-100, Trlcontanyl PVP, PEG-100 stearate, Tocopheryl Acetate, Allantoin, Dimethicone, Xanthan Gum, Cetyl Hydroxyethylcellulose, Disodium EDTA, Diazolidinyl Urea, lodopropynl Butylcarbamate, Methyldibromo Glutaronitrile, Phenoxyethanol, Methylparaben, Propylparaben, MIca (CI 77019), Blsmuth OxychlorIde (CI 77163), Iron Oxides (CI77489)

SUN TOTAL PROTECTOR COLOR 30 LIGHT TINT 
zinc oxide, octisalate, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-503
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide7.8 mL  in 100 mL
Octisalate (Octisalate) Octisalate4 mL  in 100 mL
Octinoxate (Octinoxate) Octinoxate7.5 mL  in 100 mL
Packaging
#Item CodePackage Description
1NDC:66078-503-2542 CARTON (CARTON) in 1 CASE
11 BOTTLE (BOTTLE) in 1 CARTON
175 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/20/2007
Labeler - MD Formulations (087008363)
Registrant - Harmony Labs, Inc. (105803274)
Establishment
NameAddressID/FEIOperations
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 08/2010
 
MD Formulations

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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