The following Structured Product Label (SPL) was submitted to the FDA by Skinscience Labs, Inc for the product Dr.denese Spf 30 Defense Day (NDC 66171-123). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, other safety information, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 A (Drdenesea)
Dr Denese B (Drdeneseb)
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