OBAGI MEDICAL BACK TO BASICS (INCLUDING OBAGI MEDICAL PROFESSIONAL-C SERUM 20)- homosalate, octisalate, 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® Medical Back to Basics (Including Obagi Medical Professional-C Serum 20%)

Drug Facts

Active ingredientsPurpose
Homosalate 10%Sunscreen
Octisalate 5%Sunscreen
Zinc Oxide 16.5%Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

Stop use 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

Other information

Inactive ingredients

Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (Candelilla) Wax, Beeswax (Cera Alba), Dimethicone

Questions or comments?

1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. PST

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

BACK to BASICS

OBAGI®
MEDICAL

PRINCIPAL DISPLAY PANEL - Kit Carton
OBAGI MEDICAL BACK TO BASICS (INCLUDING OBAGI MEDICAL PROFESSIONAL-C SERUM 20) 
homosalate, octisalate, and zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-693
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-693-011 in 1 CARTON04/01/2022
11 in 1 BAG
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 60 mL
Part 21 BOTTLE, PLASTIC 59 mL
Part 31 BOTTLE, DROPPER 30 mL
Part 41 TUBE 30 mL
Part 51 TUBE 28 g
Part 1 of 5
OBAGI NU-DERM FOAMING 
cleansing (cold creams, cleansing lotions, liquids, and pads) gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGR.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
INGRACETYL HEXAMETHYL TETRALIN (UNII: 360Q8Z01IP)  
INGRMEDICAGO SATIVA WHOLE (UNII: DJO934BRBD)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRBORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
INGRCHAMOMILE (UNII: FGL3685T2X)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
INGRDIHYDROMYRCENOL (UNII: 46L1B02ND9)  
INGRDIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
INGRGERANYL ACETATE (UNII: 3W81YG7P9R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRHEXYL SALICYLATE (UNII: 8F78EY72YL)  
INGRHYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
INGRISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRQUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
INGRSMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
INGRWATER (UNII: 059QF0KO0R)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRYUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
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
COSMETIC04/01/2022
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
INGR.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
INGRACETYL HEXAMETHYL TETRALIN (UNII: 360Q8Z01IP)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRBORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRDIHYDROMYRCENOL (UNII: 46L1B02ND9)  
INGRDIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
INGRGERANYL ACETATE (UNII: 3W81YG7P9R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
INGRHEXYL SALICYLATE (UNII: 8F78EY72YL)  
INGRHYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGRISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRPOTASSIUM ALUM (UNII: 1L24V9R23S)  
INGRQUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
INGRSAGE (UNII: 065C5D077J)  
INGRSMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRWATER (UNII: 059QF0KO0R)  
INGRYUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
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
COSMETIC04/01/2022
Part 3 of 5
OBAGI MEDICAL PROFESSIONAL-C SERUM 20 
face and neck (excluding shaving preparations) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRALCOHOL (UNII: 3K9958V90M)  
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
INGRCALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
INGREVERNIA PRUNASTRI (UNII: O3034Q5AHK)  
INGRGRAPEFRUIT PEEL (UNII: 3582N05Q44)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGROCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRPSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)  
INGRSORBITOL (UNII: 506T60A25R)  
INGRWATER (UNII: 059QF0KO0R)  
INGRZINC CHLORIDE (UNII: 86Q357L16B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC04/01/2022
Part 4 of 5
OBAGI MEDICAL RETINOL 
face and neck (excluding shaving preparations) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: B9J55EA6QX)  
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
INGRCHAMOMILE (UNII: FGL3685T2X)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRHYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
INGRJOJOBA OIL (UNII: 724GKU717M)  
INGRLEVOMENOL (UNII: 24WE03BX2T)  
INGRMALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGRSAGE (UNII: 065C5D077J)  
INGRSAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRSORBITOL (UNII: 506T60A25R)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRUBIDECARENONE (UNII: EJ27X76M46)  
INGRWATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC04/01/2022
Part 5 of 5
OBAGI MEDICAL SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNCREEN 
homosalate, octisalate, and zinc oxide lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
C15-19 ALKANE (UNII: CI87N1IM01)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/01/2022
Labeler - Obagi Cosmeceuticals LLC (790553353)
Establishment
NameAddressID/FEIBusiness Operations
G.S.COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-693)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208MANUFACTURE(62032-693)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933MANUFACTURE(62032-693)
Establishment
NameAddressID/FEIBusiness Operations
TENCO ASSEMBLIES, INC075535609PACK(62032-693)

Revised: 4/2022
Document Id: fb408d6d-b04a-46e8-b837-6576195b69f8
Set id: e8d19915-8996-42df-a47b-2ce00d2bbe68
Version: 1
Effective Time: 20220406
 
Obagi Cosmeceuticals LLC