Dr.Denese SPF 30 Defense Day

Dosage form: cream
Ingredients: ZINC OXIDE 7.5g in 100g, OCTINOXATE 7.5g in 100g
Labeler: SkinScience Labs, Inc
NDC Code: 66171-123

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.

Dr.Denese SPF 30 Defense Day Cream

Active Ingredients                                                     Purpose
Zinc Oxide 7.5%                                                   Sunscreen
Octinoxate 7.5% (Ethyl Hexyl Methoxycinnamate)   Sunscreen

Uses  - Helps prevent sunburn  - Higher SPF provides more protection.

Warnings  For external use only

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

- If redness and irritation develops and persists discontinue use and consult a physician.

Keep out of reach of children.

In case of accidental ingestion seek medical assistance or contact Poison Control Center immediately.

Directions  - Apply liberally to sun exposed areas 30 minutes before sun exposure or as needed.  - Children under 6 months : Consult physician. - Reapply as needed. Reapply before extended sun exposure, after swimming, towel drying, or sweating.

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.

Inactive ingredients
Cyclomethicone, Aqua (Water), Dimethicone, Polysilicone II, Glyceryl Behenate, C12-15 Alkyl Benzoate, Aloe Barbadensis Leaf Extract, Talc, Butyl Methoxydibenzolmethane, Octyldodecyl Neopentanoate, DEA Oleth-3 Phosphate, Cetyl Dimethicone Copolyol, PEG/PPG-18/18 Dimethicone, Melanine, Hydrogenated Lecithin, Butylene Glycol, Phytonadione (Vit K), Retinyl Palmitate (Vit A), Tocopheryl Acetate (Vit E), Ascorbic Acid, Ascorbyl Palmitate (Vit C), Beta Sitosterol, Niacin (Vit B3), Calcium Panthotenate (Vit B 5), Pyridoxine HCI (Vit B 6), Thiamine Nitrate (Vit B 1), Polysorbate 80, Nylon 12, Silica, Polyglyceryl-6 Octa Stearte, Glycerin, Isododecane, Propylene Glycol, Imidazolidinyl Urea, Phenoxyethanol

May Contain: Iron Oxides ( CI 77491, CI 77492, CI 77499).

Made in USA  SkinScience Labs Inc.  Ridgefield, NJ 07657  www.drdenese.com

DR. DENESE NEW YORK  SPF 30 Defense Day Cream  Broad Spectrum UVA/UVB - Matte Finish  Tinted - Oil Free Zinc-Oxide Based  4 oz (120 g)

Drug Facts  Made in USA  SkinScience Labs Inc.  Ridgefield, NJ 07657  www.drdenese.com

DR.DENESE SPF 30 DEFENSE DAY 
zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66171-123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE7.5 g  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 
WATER 
DIMETHICONE 
GLYCERYL BEHENATE 
ALKYL (C12-15) BENZOATE 
ALOE VERA LEAF 
TALC 
OCTYLDODECYL NEOPENTANOATE 
BUTYLENE GLYCOL 
PHYTONADIONE 
VITAMIN A PALMITATE 
ASCORBIC ACID 
ASCORBYL PALMITATE 
.BETA.-SITOSTEROL 
NIACIN 
THIAMINE MONONITRATE 
POLYSORBATE 80 
SILICON DIOXIDE 
GLYCERIN 
ISODODECANE 
PROPYLENE GLYCOL 
IMIDUREA 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:66171-123-01120 g in 1 TUBE
2NDC:66171-123-0245 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/21/2011
Labeler - SkinScience Labs, Inc (623794828)
Establishment
NameAddressID/FEIOperations
Englewood Lab, LLC172198223manufacture

Revised: 06/2011
 
SkinScience Labs, 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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