ZO SKIN HEALTH LEVEL III AGGRESSIVE ANTI-AGING PROGRAM WITH ADVANCED RADICAL NIGHT REPAIR- titanium dioxide and zinc oxide 
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 Skin Health (as PLD) - ZO SKIN HEALTH - LEVEL III: AGGRESSIVE ANTI-AGING PROGRAM with Advanced Radical Night Repair (42851-154) - DELIST

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 10.2%Sunscreen
Zinc Oxide 3.7%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.

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.
  • Apply to all skin exposed to the sun

Other information

  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report a serious adverse reaction to:
    1 Technology Dr., B123, Irvine, CA 92618

Inactive ingredients

Cyclopentasiloxane, Cyclotetrasiloxane,Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone Crosspolymer, Melanin,Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Alumina, Laureth-23, Methicone, PEG-10 Dimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Methylparaben, Myristoyl Pentapeptide-8, Iron Oxide (CI 77492).

DIST BY

ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO ® SKIN HEALTH
BY ZEIN OBAGI, MD

LEVEL III: AGGRESSIVE ANTI-AGING PROGRAM

with Advanced Radical Night Repair

NDC 42851-154-01

beverly hills

Principal Display Panel - Kit Carton
ZO SKIN HEALTH  LEVEL III AGGRESSIVE ANTI-AGING PROGRAM WITH ADVANCED RADICAL NIGHT REPAIR
titanium dioxide and zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-154
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-154-011 in 1 CARTON; Type 0: Not a Combination Product01/11/201212/31/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 JAR 16.2 g
Part 21 TUBE 40 mL
Part 31 JAR 50 mL
Part 41 BOTTLE, PUMP 30 mL
Part 51 TUBE, WITH APPLICATOR 30 mL
Part 61 BOTTLE, PUMP 15 mL
Part 1 of 6
OFFECTS EXFOLIATING POLISH ANTI-AGING FORMULA 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
INGRMAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGROLETH-20 (UNII: YTH167I2AG)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRTRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRSOY STEROL (UNII: PL360EPO9J)  
INGROMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
INGRTEA TREE OIL (UNII: VIF565UC2G)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRSTEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
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
Cosmetic01/11/201212/31/2020
Part 2 of 6
OFFECTS HYDRATING CLEANSER NORMAL TO DRY SKIN 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)  
INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
INGRDISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRUREA (UNII: 8W8T17847W)  
INGRTREHALOSE (UNII: B8WCK70T7I)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
INGRFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
140 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 6
OMMERSE RENEWAL ANTI-AGING FORMULA 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
INGRISOCETYL STEARATE (UNII: 3RJ7186O9W)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
INGRJOJOBA BUTTER (UNII: XIA46H803R)  
INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
INGROAT (UNII: Z6J799EAJK)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGRC10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRECTOINE (UNII: 7GXZ3858RY)  
INGRSTEARETH-21 (UNII: 53J3F32P58)  
INGRCOCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
INGRGARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRLAURETH-23 (UNII: N72LMW566G)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRMAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGRSTEARETH-2 (UNII: V56DFE46J5)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGREDETATE SODIUM (UNII: MP1J8420LU)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRSOYBEAN OIL (UNII: 241ATL177A)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGREPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
INGRSOY STEROL (UNII: PL360EPO9J)  
INGRUBIDECARENONE (UNII: EJ27X76M46)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/11/201212/31/2020
Part 4 of 6
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 (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 OLIGOPEPTIDE (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
Part 5 of 6
OSSENTIAL ADVANCED RADICAL NIGHT REPAIR ANTI-AGING FORMULA 
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRALMOND OIL (UNII: 66YXD4DKO9)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRWATER (UNII: 059QF0KO0R)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGRCYCLOMETHICONE 4 (UNII: CZ227117JE)  
INGRDIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
INGRPLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)  
INGROLEYL ALCOHOL (UNII: 172F2WN8DV)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
INGRZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
INGRGLUCONOLACTONE (UNII: WQ29KQ9POT)  
INGRBUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
INGRROSEMARY (UNII: IJ67X351P9)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRCORN OIL (UNII: 8470G57WFM)  
INGR.BETA.-CAROTENE (UNII: 01YAE03M7J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/11/201212/31/2020
Part 6 of 6
OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION 
titanium dioxide and zinc oxide lotion
Product Information
Item Code (Source)NDC:42851-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE102 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE37 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
CALCIUM BEHENATE (UNII: J5VFA9V6YG)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
LAURETH-23 (UNII: N72LMW566G)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-051-0115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/11/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/11/201212/31/2020
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 3/2023
 
ZO Skin Health, Inc.