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

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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.

Use

Helps prevent sunburn. Higher SPF gives more sun 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

Dr Denese B

DR.DENESE SPF 30 DEFENSE DAY 
zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66171-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66171-123-01120 g in 1 TUBE; Type 0: Not a Combination Product12/19/2017
2NDC:66171-123-0245 g in 1 TUBE; Type 0: Not a Combination Product12/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/21/2011
Labeler - SkinScience Labs, Inc (623794828)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab, Inc.172198223manufacture(66171-123)

Revised: 12/2023
Document Id: 0c5b74ab-a033-2667-e063-6294a90a757e
Set id: 511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa
Version: 7
Effective Time: 20231212
 
SkinScience Labs, Inc