Label: ZO SKIN HEALTH PIGMENT CONTROL PROGRAM PLUS HYDROQUINONE- hydroquinone kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 20, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    PIGMENT CONTROL CREME

    (Hydroquinone USP, 4%)

    RX ONLY

    FOR EXTERNAL USE ONLY:

    NOT FOR OPHTHALMIC USE

  • DESCRIPTION

    Hydroquinone is 1,4-benzendiol, with a chemical formula of C6H6O2 and a molecular weight of 110.11.

    The structural formula is:

    Chemical Structure

    Each gram of Pigment Control Creme (Hydroquinone USP, 4%) contains Hydroquinone USP 40 mg/gm in a base of Purified Water, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Phenoxyethanol, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

  • CLINICAL PHARMACOLOGY

    Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause re-pigmentation of bleached areas, which may be prevented by the use of the sunscreen agents.

  • INDICATIONS AND USAGE

    Pigment Control Creme is indicated in the gradual bleaching of hyperpigmentation, skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

  • CONTRAINDICATIONS

    Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical Hydroquinone use during pregnancy or in children (12 years and under) has not been established.

  • WARNINGS

    Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product.

    Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

    Avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation from occurring.

    Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician.

    Avoid contact with eyes and mucous membranes. Keep out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

  • PRECAUTIONS

    Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

    Drug Interactions

    Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

    Pregnancy Category C

    Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

  • Adverse Reactions

    The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

  • Overdosage

    There have been no system reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

  • DRUG DOSAGE AND ADMINISTRATION

    A thin layer of Pigment Control Creme (Hydroquinone USP, 4%) should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after 8-12 weeks of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

  • HOW SUPPLIED

    Pigment Control Creme (Hydroquinone USP, 4%) is available as follows:

    2.7 Fl. Oz. (80 mL) Bottle / NDC 42851-037-80

    1.0 fl oz/30 ml Bottle / NDC 42851-037-30

    STORAGE

    Store at controlled room temperature: 15°-30°C (59°-86°F)

  • SPL UNCLASSIFIED SECTION

    PIGMENT CONTROL + BLENDING CREME
    (Hydroquinone USP, 4%)

    RX ONLY
    FOR EXTERNAL USE ONLY:
    NOT FOR OPHTHALMIC USE

  • DESCRIPTION

    Hydroquinone is 1,4-benzendiol, with a chemical formula of C6H6O2 and a molecular weight of 110.11.

    The structural formula is:

    Chemical Structure

    Each gram of Pigment Control + Blending Creme contains Hydroquinone USP 40mg/gm in a base of Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Purified Water, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

  • CLINICAL PHARMACOLOGY

    Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause re-pigmentation of bleached areas, which may be prevented by the use of the sunscreen agents.

  • INDICATIONS AND USAGE

    For the gradual bleaching of hyperpigmented skin conditions such as cholasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

  • CONTRAINDICATIONS

    Prior history of sensitivity or allergic reaction to hydroquinone or to any other ingredient in this product. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

  • WARNINGS

    Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product.

    Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

    Avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation from occurring.

    Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician.

    Avoid contact with eyes and mucous membranes. Keep out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

  • PRECAUTIONS

    Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

    Drug Interactions

    Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

    Pregnancy Category C

    Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

  • Adverse Reactions

    The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

  • Overdosage

    There have been no system reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

  • DRUG DOSAGE AND ADMINISTRATION

    A thin application of Pigment Control + Blending Creme should be applied to the affected area twice daily or as directed by a physician. Consult product label for instructions on whether to rub in or not. There is no recommendation for children under 12 years of age except under the advice and supervision of a physician.

  • HOW SUPPLIED

    Pigment Control + Blending Creme (Hydroquinone USP, 4%) is available as follows:

    2.7 Fl. Oz. (80 mL) Bottle / NDC 42851-036-80

    1.0 Fl. Oz (30 mL) Bottle / NDC 42851-036-30

    STORAGE

    Store at controlled room temperature: 15°-30°C (59°-86°F)

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO ® SKIN HEALTH

    BY ZEIN OBAGI MD

    PIGMENT CONTROL PROGRAM

    + HYDROQUINONE

    NDC 42851-184-60

    GENTLE CLEANSER 60 mL / 2 Fl. Oz.

    EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.

    COMPLEXION RENEWAL PADS 30 Pads

    PIGMENT CONTROL CRÈME 30 mL / 1.0 Fl. Oz.

    DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.

    PIGMENT CONTROL + BLENDING CREME 30 mL / 1 Fl. Oz.

    US Pigment Control + Hydroquinone Kit UC.jpg

  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH PIGMENT CONTROL PROGRAM PLUS HYDROQUINONE 
    hydroquinone kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-184
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-184-601 in 1 CARTON03/09/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 60 mL
    Part 21 JAR 16.2 g
    Part 330 JAR 30 
    Part 41 BOTTLE, PLASTIC 30 mL
    Part 51 BOTTLE, PLASTIC 30 mL
    Part 61 BOTTLE, PUMP 30 mL
    Part 1 of 6
    ZO SKIN HEALTH GENTLE CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads) gel
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRLIMONENE, (+/-)- (UNII: 9MC3I34447)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/09/2021
    Part 2 of 6
    ZO SKIN HEALTH EXFOLIATING POLISH 
    lotions, oils, powders, and creams suspension
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRMAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGROLETH-20 (UNII: YTH167I2AG)  
    INGRTRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGR.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    INGRTEA TREE OIL (UNII: VIF565UC2G)  
    INGRSOY STEROL (UNII: PL360EPO9J)  
    INGRLIMONENE, (+/-)- (UNII: 9MC3I34447)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRSTEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRD&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116.2 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/09/2021
    Part 3 of 6
    ZO SKIN HEALTH COMPLEXION RENEWAL PADS 
    cleansing (cold creams, cleansing lotions, liquids, and pads) patch
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRALCOHOL (UNII: 3K9958V90M)  
    INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRGLYCOLIC ACID (UNII: 0WT12SX38S)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM CARBONATE (UNII: 45P3261C7T)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRDENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    INGR.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRBARLEY (UNII: 5PWM7YLI7R)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRTERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    INGRPTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRPLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
    INGRPHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    INGRCRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/09/2021
    Part 4 of 6
    ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE 
    hydroquinone emulsion
    Product Information
    Item Code (Source)NDC:42851-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
    SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/09/2021
    Part 5 of 6
    ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE 
    hydroquinone emulsion
    Product Information
    Item Code (Source)NDC:42851-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.04 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
    SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    WATER (UNII: 059QF0KO0R)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/09/2021
    Part 6 of 6
    ZO SKIN HEALTH DAILY POWER DEFENSE 
    other skin care preparations lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRC12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    INGRLACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRHYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    INGRPALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGREXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    INGRULTRAMARINE BLUE (UNII: I39WR998BI)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRC14-22 ALCOHOLS (UNII: B1K89384RJ)  
    INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    INGRWATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/09/2021
    Labeler - ZO Skin Health, Inc. (826468527)