OBAGI SKINTRINSIQ FIRMING PROTOCOL- titanium dioxide and zinc oxide 
Obagi Cosmeceuticals LLC

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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Obagi ® Skintrinsiq Firming Protocol Kit

Obagi ® Sun Shield Mineral Broad Spectrum SPF 50 Sunscreen

Drug Facts

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

Uses

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 a doctor if rash occurs

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

Directions

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

Questions or comments?

1.800.636.7546

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

Distributed by Obagi Cosmeceuticals LLC
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

SKINTRINSIQ™

FIRMING
PROTOCOL KIT

INCLUDES:

OBAGI ®

PRINCIPAL DISPLAY PANEL - Kit Carton

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

OBAGI™
MEDICAL

Sun Shield

MINERAL

Broad
Spectrum
SPF 50

Sunscreen
Lotion

PA++++
Non-comedogenic
Dermatologist Tested

Net wt. 3 oz. (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
OBAGI SKINTRINSIQ FIRMING PROTOCOL 
titanium dioxide and zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-910
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-910-101 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, PUMP 30 mL
Part 41 JAR 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
OBAGI ELASTIDERM FACE SERUM 
face and neck (excluding shaving preparations) gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRALCOHOL (UNII: 3K9958V90M)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
INGRAMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)  
INGRBASIC CUPRIC CARBONATE (UNII: GIK928GH0Y)  
INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
INGRCOCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
INGRISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
INGRMALONIC ACID (UNII: 9KX7ZMG0MK)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRTERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
INGRWATER (UNII: 059QF0KO0R)  
INGRZINC CARBONATE (UNII: EQR32Y7H0M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
130 mL 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 4 of 5
OBAGI HYDRATE LUXE 
moisturizing cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGRCAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
INGRCAPROOYL TETRAPEPTIDE-3 (UNII: LZI0HJ3K2R)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRDEXTRAN 40 (UNII: K3R6ZDH4DU)  
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)  
INGRPREZATIDE (UNII: 39TG2H631E)  
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 JAR; 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(62032-910)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(62032-910)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(62032-910)
Establishment
NameAddressID/FEIBusiness Operations
TENCO ASSEMBLIES, INC075535609pack(62032-910)

Revised: 3/2023
Document Id: f7fcde32-7c61-aa93-e053-6294a90abde0
Set id: 67ba9f32-bbf4-4c14-9e97-08f1cb7d3996
Version: 2
Effective Time: 20230328
 
Obagi Cosmeceuticals LLC