DR.DENESE SPF 30 DEFENSE DAY- zinc oxide, octinoxate cream

Dr.Denese SPF 30 Defense Day by

Drug Labeling and Warnings

Dr.Denese SPF 30 Defense Day by is a Otc medication manufactured, distributed, or labeled by SkinScience Labs, Inc, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

WARNINGS

Warnings  For external use only

WHEN USING

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

STOP USE

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

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

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)

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.DENESE SPF 30 DEFENSE DAY 
zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66171-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
IMIDUREA (UNII: M629807ATL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TALC (UNII: 7SEV7J4R1U)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHYTONADIONE (UNII: A034SE7857)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
NIACIN (UNII: 2679MF687A)
THIAMINE MONONITRATE (UNII: 8K0I04919X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66171-123-01	120 g in 1 TUBE; Type 0: Not a Combination Product	12/19/2017
2	NDC: 66171-123-02	45 g in 1 TUBE; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/21/2011

Labeler - SkinScience Labs, Inc (623794828)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(66171-123)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(66171-123)