FDA Label for Dr.denese Spf 30 Defense Day

View Indications, Usage & Precautions

Dr.denese Spf 30 Defense Day Product Label

The following document was submitted to the FDA by the labeler of this product Skinscience Labs, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Otc - Purpose



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


Warnings



Warnings  For external use only


Otc - When Using



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


Otc - Stop Use



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Other Safety Information



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


Dosage & Administration



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.


Precautions



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 Ingredient



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).


Description



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


Package Label.Principal Display Panel



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


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