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ZO SKIN HEALTH LEVEL II ANTI-AGING PROGRAM with Growth Factor Serum Plus

Dosage form: kit
Ingredients: ; Titanium Dioxide 102mg in 1mL, Zinc Oxide 37mg in 1mL
Labeler: ZO Skin Health, Inc.
NDC Code: 42851-153

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.

ZO® SKIN HEALTH
LEVEL II: ANTI-AGING PROGRAM with Growth Factor Serum Plus

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 II: ANTI-AGING PROGRAM

with Growth Factor Serum Plus

NDC 42851-153-01

beverly hills

Established Pharmacological Class
SubstancePharmacological Class
OFFECTS EXFOLIATING CLEANSER NORMAL TO DRY SKIN ANTI-AGING FORMULACLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OFFECTS EXFOLIATING POLISH ANTI-AGING FORMULACLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULACLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OSSENTIAL GROWTH FACTOR SERUM PLUS ANTI-AGING FORMULACLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
ZO SKIN HEALTH  LEVEL II ANTI-AGING PROGRAM WITH GROWTH FACTOR SERUM PLUS
titanium dioxide and zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-153
Packaging
#Item CodePackage Description
1NDC:42851-153-011 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 40 mL
Part 21 JAR 16.2 g
Part 31 BOTTLE, PUMP 30 mL
Part 41 BOTTLE, PUMP 30 mL
Part 51 BOTTLE, PUMP 15 mL
Part 1 of 5
OFFECTS EXFOLIATING CLEANSER NORMAL TO DRY SKIN ANTI-AGING FORMULA 
inert lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
SODIUM LAURETH-3 SULFATE 
COCAMIDOPROPYL BETAINE 
HIGH DENSITY POLYETHYLENE 
GLYCERIN 
COCAMIDOPROPYL HYDROXYSULTAINE 
SODIUM HYDROXIDE 
MANNITOL 
Disodium Cocoamphodiacetate 
CHROMIUM HYDROXIDE GREEN 
POWDERED CELLULOSE 
Butylene Glycol 
FILIPENDULA ULMARIA ROOT 
TEA TREE OIL 
Salicylic Acid 
SODIUM PYRROLIDONE CARBOXYLATE 
NIACIN 
NIACINAMIDE 
AMMONIUM LACTATE 
.ALPHA.-TOCOPHEROL ACETATE 
HYPROMELLOSES 
BIOSACCHARIDE GUM-1 
EDETATE DISODIUM 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
MAGNESIUM CHLORIDE 
MAGNESIUM NITRATE 
Packaging
#Item CodePackage Description
140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/11/2012
Part 2 of 5
OFFECTS EXFOLIATING POLISH ANTI-AGING FORMULA 
inert cream
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
POLYETHYLENE GLYCOL 400 
SODIUM BICARBONATE 
DIETHYLENE GLYCOL MONOETHYL ETHER 
MAGNESIUM OXIDE 
GLYCERIN 
Oleth-20 
GLYCERYL MONOSTEARATE 
TRIHYDROXYSTEARIN 
PEG-100 Stearate 
TETRAHEXYLDECYL ASCORBATE 
.ALPHA.-TOCOPHEROL ACETATE 
VITAMIN A PALMITATE 
ASCORBYL PALMITATE 
MEDIUM-CHAIN TRIGLYCERIDES 
LINOLEIC ACID 
OMEGA-3 FATTY ACIDS 
TEA TREE OIL 
PROPYLPARABEN 
STEARYL GLYCYRRHETINATE 
D&C GREEN NO. 6 
Packaging
#Item CodePackage Description
116.2 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/11/2012
Part 3 of 5
OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA 
inert lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
CETEARYL ISONONANOATE 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
PENTYLENE GLYCOL 
RETINOL 
EGG PHOSPHOLIPIDS 
POLYSORBATE 20 
GLYCERIN 
STEARETH-20 
CETOSTEARYL ALCOHOL 
JOJOBA BUTTER 
VITAMIN A PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE 
CURDLAN 
LACTOSE 
ORANGE OIL 
MANDARIN OIL 
LEMON OIL 
PEPPERMINT OIL 
MIMOSA TENUIFLORA BARK 
ARABIDOPSIS THALIANA 
C14-22 ALCOHOLS 
CETEARYL GLUCOSIDE 
C12-20 ALKYL GLUCOSIDE 
POWDERED CELLULOSE 
BUTYLENE GLYCOL 
PALMITOYL OLIGOPEPTIDE 
PALMITOYL TETRAPEPTIDE-7 
SODIUM HYDROXIDE 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
HYPROMELLOSES 
HEXYLENE GLYCOL 
EDETATE DISODIUM 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
LIMONENE, (+/-)- 
ULTRAMARINE BLUE 
EXT. D&C VIOLET NO. 2 
Packaging
#Item CodePackage Description
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/11/2012
Part 4 of 5
OSSENTIAL GROWTH FACTOR SERUM PLUS ANTI-AGING FORMULA 
inert gel
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
CYCLOMETHICONE 5 
DIPROPYLENE GLYCOL 
GLYCERIN 
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER 
DIMETHICONE 
PROPYLENE GLYCOL 
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) 
DIMETHICONOL (40 CST) 
BUTYLENE GLYCOL 
CURDLAN 
AMINOPROPYL DIHYDROGEN PHOSPHATE 
PHENOXYETHANOL 
N-ACETYL-TYROSINE 
MAGNESIUM SULFATE 
OMEGA-3 FATTY ACIDS 
PANTHENOL TRIACETATE, (+)- 
ETHYL LINOLEATE 
SODIUM PHOSPHATE 
HYDROLYZED SERICIN (ENZYMATIC; 2500 MW) 
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE 
OLEYL ALCOHOL 
PROLINE 
Retinol 
POLYSORBATE 20 
ANGELICA SINENSIS ROOT 
ADENOSINE TRIPHOSPHATE 
ASIAN GINSENG 
TOCOPHEROL 
CAPRYLYL GLYCOL 
POTASSIUM SORBATE 
XANTHAN GUM 
HEXYLENE GLYCOL 
1,2-HEXANEDIOL 
BUTYLATED HYDROXYTOLUENE 
Sodium Chloride 
BUTYLATED HYDROXYANISOLE 
Packaging
#Item CodePackage Description
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/11/2012
Part 5 of 5
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide102 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide37 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
CYCLOMETHICONE 4 
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) 
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER 
TRIBEHENIN 
CALCIUM BEHENATE 
SORBITAN ISOSTEARATE 
DIMETHICONOL (40 CST) 
ALUMINUM OXIDE 
LAURETH-23 
METHICONE (20 CST) 
PEG-10 DIMETHICONE (600 CST) 
PPG-2 MYRISTYL ETHER PROPIONATE 
PROPYLPARABEN 
METHYLPARABEN 
FERRIC OXIDE RED 
Packaging
#Item CodePackage Description
1NDC:42851-051-0115 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/11/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/11/2012
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIOperations
Lifetech Resources622559110MANUFACTURE(42851-153)
Establishment
NameAddressID/FEIOperations
PakLab, Inc.177711082MANUFACTURE(42851-153)
Establishment
NameAddressID/FEIOperations
Product Quest927768135MANUFACTURE(42851-153)
Establishment
NameAddressID/FEIOperations
Owen Biosciences790003045MANUFACTURE(42851-153)

 
ZO Skin Health, Inc.

Medically reviewed on Feb 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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