ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION- titanium dioxide 
ZO Skin Health, Inc.

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.

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ZO MEDICAL (as PLD) - ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM (42851-156) - DELIST

Drug Facts

Active ingredient

Titanium Dioxide 8%

Purpose

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.

Stop and ask a doctor if rash occurs.

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

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Other information

  • Store product in a cool place away from direct heat and sunlight.
  • You may report a serious adverse reaction to: 5 Technology Dr. #100, Irvine, CA 92618

Directions

  • For full protection, apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • For children under 6 months of age: 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.
  • Apply to all skin exposed to the sun.

Inactive ingredients

Water, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides, Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja (Soybean) Extract, Silica, C13-14 Isoparaffin, Laureth-7.

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO ® MEDICAL
BY ZEIN OBAGI MD

NDC 42851-156-60

ZO ® NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM

For Restoring Even Skin Tone

Principal Display Panel - Kit Carton
ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION 
titanium dioxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-156
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-156-601 in 1 CARTON06/01/201412/31/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 30 mL
Part 21 TUBE 30 mL
Part 31 TUBE 60 g
Part 41 TUBE 30 mL
Part 51 BOTTLE, PUMP 30 mL
Part 1 of 5
RETAMAX ACTIVE VITAMIN A MICRO EMULSION  
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGRPROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
INGRBROCCOLI (UNII: UOI4FT57BZ)  
INGRPOLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRHYDROLYZED SERICIN (ENZYMATIC; 2500 MW) (UNII: 02EMA6F96C)  
INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRCYCLOMETHICONE 4 (UNII: CZ227117JE)  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGRMYRISTYL ALCOHOL (UNII: V42034O9PU)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGRLINALYL ACETATE (UNII: 5K47SSQ51G)  
INGRCURDLAN (UNII: 6930DL209R)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRBUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
INGRPELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
INGRETHYL NICOTINATE (UNII: NIJ3H353YH)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
INGRCARVOMENTHONE (UNII: D5PYY1B83Q)  
INGRLAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
INGR.ALPHA.-OCIMENE, (3Z)- (UNII: LTP9229T5N)  
INGR4-CARVOMENTHENOL (UNII: L65MV77ZG6)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGREXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/11/201212/31/2020
Part 2 of 5
BRIGHTENEX SKIN BRIGHTENER AND CORRECTING, NON-HYDROQUINONE  
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRALMOND OIL (UNII: 66YXD4DKO9)  
INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRCYCLOMETHICONE 4 (UNII: CZ227117JE)  
INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
INGRGLUTATHIONE (UNII: GAN16C9B8O)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRPROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRN-ACETYLGLUCOSAMINE (UNII: V956696549)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRSOY ISOFLAVONES (UNII: 71B37NR06D)  
INGRPOLYSORBATE 61 (UNII: X9E1MY2JQG)  
INGRALCOHOL (UNII: 3K9958V90M)  
INGRNYLON-12 (UNII: 446U8J075B)  
INGR.BETA.-CAROTENE (UNII: 01YAE03M7J)  
INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
INGRCORN OIL (UNII: 8470G57WFM)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGRBUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRGLUCONOLACTONE (UNII: WQ29KQ9POT)  
INGRPOLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRGERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/11/201212/31/2020
Part 3 of 5
ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50  
titanium dioxide lotion
Product Information
Item Code (Source)NDC:42851-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
MELAMINE (UNII: N3GP2YSD88)  
ERYTHRITOL (UNII: RA96B954X6)  
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
NEPHELIUM LAPPACEUM FRUIT RIND (UNII: Y0513T90FO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-052-6060 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02006/01/201312/31/2020
Part 4 of 5
RESTORACALM SOOTHING RECOVERY  
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRBIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
INGRJOJOBA BUTTER (UNII: XIA46H803R)  
INGRCURDLAN (UNII: 6930DL209R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRC10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRDICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
INGRISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
INGRETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
INGRARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
INGRDOCOSANOL (UNII: 9G1OE216XY)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRN-ACETYLTYROSINE (UNII: DA8G610ZO5)  
INGRHYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRHYDROLYZED SERICIN (ENZYMATIC; 2500 MW) (UNII: 02EMA6F96C)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRETHYL FERULATE (UNII: 5B8915UELW)  
INGRPOLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
INGRROSEMARY (UNII: IJ67X351P9)  
INGRURIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)  
INGRSULFURYL FLUORIDE (UNII: 64B59K7U6Q)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
INGRPROLINE (UNII: 9DLQ4CIU6V)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGRPOTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
INGRANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
INGRADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGRBUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/11/201212/31/2020
Part 5 of 5
OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA  
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRJOJOBA BUTTER (UNII: XIA46H803R)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRCURDLAN (UNII: 6930DL209R)  
INGRLACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
INGRORANGE OIL (UNII: AKN3KSD11B)  
INGRMANDARIN OIL (UNII: NJO720F72R)  
INGRLEMON OIL (UNII: I9GRO824LL)  
INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
INGRC14-22 ALCOHOLS (UNII: B1K89384RJ)  
INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
INGRC12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRPALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
INGRHYPROMELLOSES (UNII: 3NXW29V3WO)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRLIMONENE, (+/-)- (UNII: 9MC3I34447)  
INGRULTRAMARINE BLUE (UNII: I39WR998BI)  
INGREXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
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
Cosmetic01/11/201212/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02005/01/201412/31/2020
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 3/2023
 
ZO Skin Health, Inc.