Label: OBAGI SKINTRINSIQ CLARIFIYING PROTOCOL- salicylic acid, titanium dioxide, and zinc oxide kit

  • NDC Code(s): 62032-612-04, 62032-811-09, 62032-909-09
  • Packager: Obagi Cosmeceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Obagi ® Medical CLENZIderm M.D. ® Pore Therapy

    Drug Facts

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Acne treatment

  • Uses

    • or the treatment of acne
    • dries up acne pimples
    • helps prevent new acne pimples
  • Warnings

    For external use only

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

    Stop use and ask a doctor if irritation becomes severe.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Cleanse the skin thoroughly before applying this product.
    • Shake product well before use.
    • Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Other information

    • store away from heat and direct sunlight
    • store at controlled room temperature: 15°–25°C (59°–77°F)
  • Inactive ingredients

    benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

  • Questions or comments?

    1.800.636.7546 Monday–Friday 9a.m.–4p.m. Pacific Time

  • SPL UNCLASSIFIED SECTION

    Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

  • SPL UNCLASSIFIED SECTION

    Obagi™ Sun Shield Mineral Broad Spectrum SPF 50 Sunscreen

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium dioxide 6.2%Sunscreen
    Zinc oxide 15.6%Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken skin

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

    Stop use and ask doctor if rash occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m.–2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses
  • Inactive ingredients

    Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Pentylene Glycol, Steareth-2, Glycerin, Silica, Polyhydroxystearic Acid, Steareth-21, Cetearyl Alcohol, Propanediol, Alumina, Stearic Acid, Sodium Stearoyl Glutamate, Caprylyl Glycol, Triethoxycaprylylsilane, Cetearyl Glucoslde, Xanthan Gum, Dipotassium Glycyrrhizate,Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Tropaeolum Majus Flower/Leaf/Stem Extract

  • Other information

    • store at controlled room temperature: 15°C–25°C (59°F–77°F)
    • protect this product from excessive heat and direct sun
  • Questions or comments?

    1.800.636.7546

    Monday–Friday 9 a.m.–4 p.m. Pacific Time

  • SPL UNCLASSIFIED SECTION

    Distributed by Obagi Cosmeceuticals LLC
    Long Beach, CA 90806

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    SKINTRINSIQ™

    CLARIFYING
    PROTOCOL KIT

    INCLUDES:

    • 60 Tips
    • Obagi Nu-Derm ® Gentle Cleanser, 2 FL. OZ.
    • Obagi Nu-Derm ® Toner, 2 FL. OZ.
    • CLENZIderm M.D. ® Pore Therapy, 5 FL. OZ.
    • Obagi Hydrate ® Facial Moisturizer, 1.7 OZ.
    • Obagi Sun Shield™ Mineral Broad Spectrum SPF 50 Sunscreen, 3 OZ.

    OBAGI ®

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

    OBAGI ®
    MEDICAL

    CLENZIderm M.D. ®

    Pore Therapy

    Salicylic Acid 2%
    Acne Treatment

    5 FL. OZ. (148 mL)

    PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    OBAGI™
    MEDICAL

    Sun Shield
    Broad
    Spectrum
    SPF 50

    MINERAL

    Sunscreen
    Lotion

    PA++++
    Non-comedogenic
    Dermatologist Tested

    Net wt. 3 oz. (85 g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    OBAGI SKINTRINSIQ CLARIFIYING PROTOCOL 
    salicylic acid, titanium dioxide, and zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-909
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-909-091 in 1 BOX08/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 60 mL
    Part 21 BOTTLE, PLASTIC 59 mL
    Part 31 BOTTLE, PLASTIC 148 mL
    Part 41 BOTTLE, PUMP 48 g
    Part 51 TUBE 85 g
    Part 1 of 5
    OBAGI NU-DERM GENTLE CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads) gel
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
    INGRBORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGROLEYL LACTATE (UNII: B3AWW0N3GM)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRSAGE (UNII: 065C5D077J)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRWATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/01/2021
    Part 2 of 5
    OBAGI NU-DERM TONER 
    face and neck (excluding shaving preparations) liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRBORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    INGRPOTASSIUM ALUM (UNII: 1L24V9R23S)  
    INGRSAGE (UNII: 065C5D077J)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRWATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/01/2021
    Part 3 of 5
    CLENZIDERM PORE THERAPY  ACNE TREATMENT
    salicylic acid liquid
    Product Information
    Item Code (Source)NDC:62032-612
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-612-04148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00608/01/2021
    Part 4 of 5
    OBAGI HYDRATE FACIAL MOISTURIZER 
    moisturizing lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
    INGRCAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRLAURETH-12 (UNII: OAH19558U1)  
    INGRLEVOMENOL (UNII: 24WE03BX2T)  
    INGRMANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRSODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    INGRSOY STEROL (UNII: PL360EPO9J)  
    INGRSOYBEAN (UNII: L7HT8F1ZOD)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRTETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRWATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    148 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/01/2021
    Part 5 of 5
    SUN SHIELD MINERAL BROAD SPECTRUM SPF 50  SUNSCREEN
    titanium dioxide and zinc oxide lotion
    Product Information
    Item Code (Source)NDC:62032-811
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.2 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    TROPAEOLUM MAJUS FLOWERING TOP (UNII: RGT30824HY)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-811-091 in 1 CARTON
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/01/2021
    Labeler - Obagi Cosmeceuticals LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S.COSMECEUTICAL USA, INC.017014734manufacture(62032-909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(62032-909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(62032-909)
    Establishment
    NameAddressID/FEIBusiness Operations
    TENCO ASSEMBLIES, INC075535609pack(62032-909)
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