DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]

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DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]
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NDC 66171-123-01, 66171-123-02
Set ID 511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa
Category HUMAN OTC DRUG LABEL
Packager SkinScience Labs, Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • 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

    Dr Denese A

  • PRINCIPAL DISPLAY PANEL

    Dr Denese B

  • INGREDIENTS AND APPEARANCE
    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 finalpart35205/21/2011
    Labeler - SkinScience Labs, Inc (623794828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(66171-123)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Korea Co., Ltd.690104005manufacture(66171-123)
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