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Name:Balancing Daily Defense Spf 15
Manufacturer:Wasatch Product Development, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Daily Defense Lotion

 BALANCING DAILY DEFENSE SPF 15 - octinoxate and zinc oxide cream 
Wasatch Product Development, Inc.

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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Daily Defense Lotion

Active Ingredients:

Ethylhexyl Methoxycinnamate 7.5%

Zinc Oxide 3%

Warnings: For external use only. Avoid contact with eyes. Rinse with water if eye contact occurs. Discontinue use and consult a doctor if rash or irritation develops and persists. Keep out of reach of children

Application: with fingertips, smooth gently and evenly over face and neck.

Inactive Ingredients: Water (Aqua), Ethylhexyl Isononanoate, Pentylene Glycol, Octyldodecyl Neopentanoate, Sucrose Cocoate, Cetearyl Alcohol, Polyglyceryl-3 Distearate, Steareth-20, Behenyl Alcohol, Magnesium Aluminum Silicate, Potassium Cetyl Phosphate, Squalane, Xanthan Gum, Dimethicone PEG-7, Tocopheryl Acetate (Vitamin E), Fragrance (essential oils), Disodium EDTA, Caprylic/Capric Triglyceride, Phenoxyethanol, Panthenyl Triacetate (Vitamin B), Chlorphenesin, Glycerin, Methylparaben, Algae Extract, Artemisia Princeps Leaf Extract, Benzoic Acid, Zea Mays (Corn) Oil, Glycine Soja (Soybean) Seed Extract, Glycine Soja (soybean) lipids, farnesyl acetate, farnesol, tetrahexyldecyl ascorbate (Vitamin C),  Panax Ginseng Root extract, Chamomilla recutita ( matricaria) flower extract, Ulva lactuca (sea lettuce) extract, Ginkgo biloba leaf extract, sodium PCA, retinyl palmitate (vitamine A), Plankton Extract, Ergothioneine, Aloe Barbadensis, Vitis Vinifera (grape) seed extract, Camellia Oleifera (green tea) leaf extractt, lecithin, citric acid

image of seconday label

Natria
Balancing Daily Defense Lotion SPF 15
75 ml/ 2.5 fl. oz.
image of primary label


  BALANCING DAILY DEFENSE SPF 15
ethylhexyl methoxycinnamate, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44717-534
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44717-534-02 1 TUBE ( TUBE) in 1 BOX contains a TUBE (44717-534-01)
1 NDC:44717-534-01 75 mL in 1 TUBE This package is contained within the BOX (44717-534-02)

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

Labeler - Wasatch Product Development, Inc. (962452533)
Registrant - Natures Sunshine (081832388)
Establishment
Name Address ID/FEI Operations
Wasatch Product Development, Inc. 962452533 manufacture

Revised: 07/2010 Wasatch Product Development, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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