OTC Medication Information: Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)

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.

Drug Facts

Active ingredients Purpose
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Zinc Oxide 16.5% 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 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

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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
  • children under 6 months: Ask a doctor

Other information

  • store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • protect this product from excessive heat and direct sun

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
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
OBAGI NU-DERM FOAMING CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OBAGI NU-DERM TONER FACE AND NECK (EXCLUDING SHAVING PREPARATIONS)
OBAGI MEDICAL PROFESSIONAL-C SERUM 20 FACE AND NECK (EXCLUDING SHAVING PREPARATIONS)
OBAGI MEDICAL RETINOL FACE AND NECK (EXCLUDING SHAVING PREPARATIONS)
OBAGI MEDICAL BACK TO BASICS (INCLUDING OBAGI MEDICAL PROFESSIONAL-C SERUM 20)
homosalate, octisalate, and zinc oxide kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-693
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-693-01 1 BAG in 1 CARTON contains a BAG
1 1 KIT in 1 BAG This package is contained within the CARTON (62032-693-01)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 60 mL
Part 2 1 BOTTLE, PLASTIC 59 mL
Part 3 1 BOTTLE, DROPPER 30 mL
Part 4 1 TUBE 30 mL
Part 5 1 TUBE 28 g
Part 1 of 5
OBAGI NU-DERM FOAMING
gel
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
.ALPHA.-AMYLCINNAMALDEHYDE
ACETYL HEXAMETHYL TETRALIN
MEDICAGO SATIVA WHOLE
ALOE VERA LEAF
BORAGO OFFICINALIS SEED
BUTYLPARABEN
BUTYLPHENYL METHYLPROPIONAL
CHAMOMILE
COCAMIDOPROPYL BETAINE
D&C RED NO. 33
DIHYDROMYRCENOL
DIOSCOREA VILLOSA TUBER
ETHYLPARABEN
FD&C YELLOW NO. 5
GERANYL ACETATE
GLYCERIN
HEXYL SALICYLATE
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE
ISOBUTYLPARABEN
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
METHYLPARABEN
PHENOXYETHANOL
PHENYLETHYL ALCOHOL
PROPYLPARABEN
QUILLAJA SAPONARIA BARK
SMILAX ARISTOLOCHIIFOLIA ROOT
SODIUM CHLORIDE
SODIUM LAURETH-3 SULFATE
SODIUM LAUROYL OAT AMINO ACIDS
WATER
XANTHAN GUM
YUCCA SCHIDIGERA ROOT
Packaging
# Item Code Package Description Multilevel Packaging
1 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
COSMETIC 04/01/2022
Part 2 of 5
OBAGI NU-DERM TONER
liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
.ALPHA.-AMYLCINNAMALDEHYDE
ACETYL HEXAMETHYL TETRALIN
ALLANTOIN
ALOE VERA LEAF
BORAGO OFFICINALIS SEED
BUTYLPHENYL METHYLPROPIONAL
CALENDULA OFFICINALIS FLOWER
DIHYDROMYRCENOL
DIOSCOREA VILLOSA TUBER
DMDM HYDANTOIN
FD&C BLUE NO. 1
GERANYL ACETATE
GLYCERIN
HAMAMELIS VIRGINIANA TOP WATER
HEXYL SALICYLATE
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE
IODOPROPYNYL BUTYLCARBAMATE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
PANTHENOL
PHENYLETHYL ALCOHOL
POLYSORBATE 80
POTASSIUM ALUM
QUILLAJA SAPONARIA BARK
SAGE
SMILAX ARISTOLOCHIIFOLIA ROOT
SODIUM PYRROLIDONE CARBOXYLATE
WATER
YUCCA SCHIDIGERA ROOT
Packaging
# Item Code Package Description Multilevel Packaging
1 59 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
COSMETIC 04/01/2022
Part 3 of 5
OBAGI MEDICAL PROFESSIONAL-C SERUM 20
liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
ALCOHOL
ASCORBIC ACID
ASCORBYL GLUCOSIDE
CALCIUM HYDROXIDE
DIETHYLENE GLYCOL MONOETHYL ETHER
EVERNIA PRUNASTRI
GRAPEFRUIT PEEL
HYALURONATE SODIUM
OCTOXYNOL-9
PHENOXYETHANOL
PROPYLENE GLYCOL
PSEUDEVERNIA FURFURACEA
SORBITOL
WATER
ZINC CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
COSMETIC 04/01/2022
Part 4 of 5
OBAGI MEDICAL RETINOL
cream
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
.ALPHA.-TOCOPHEROL ACETATE
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
ASCORBIC ACID
BUTYLATED HYDROXYTOLUENE
BUTYLENE GLYCOL
CAPRYLYL GLYCOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
CHAMOMILE
CYCLOMETHICONE 5
CYCLOMETHICONE 6
DIMETHICONE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
EDETATE DISODIUM
ETHYLHEXYLGLYCERIN
GLYCERIN
GLYCERYL MONOSTEARATE
GLYCYRRHIZINATE DIPOTASSIUM
HEXYLENE GLYCOL
HYALURONATE SODIUM
HYPERICUM PERFORATUM FLOWER
JOJOBA OIL
LEVOMENOL
MALVA SYLVESTRIS FLOWER
MEDIUM-CHAIN TRIGLYCERIDES
PHENOXYETHANOL
POLYSORBATE 20
POLYSORBATE 60
PROPYLENE GLYCOL
RETINOL
SAGE
SAMBUCUS NIGRA FLOWER
SHEA BUTTER
SORBITOL
STEARIC ACID
STEARYL ALCOHOL
TROLAMINE
UBIDECARENONE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TUBE in 1 CARTON contains a TUBE
1 30 mL in 1 TUBE This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
COSMETIC 04/01/2022
Part 5 of 5
OBAGI MEDICAL SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNCREEN
homosalate, octisalate, and zinc oxide lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 16.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
1,2-HEXANEDIOL
C15-19 ALKANE
CANDELILLA WAX
CAPRYLYL GLYCOL
DIMETHICONE
DISTEARDIMONIUM HECTORITE
EDETATE DISODIUM ANHYDROUS
GLYCERIN
HYDROXYACETOPHENONE
OCTYLDODECYL NEOPENTANOATE
POLYGLYCERYL-2 ISOSTEARATE
POLYGLYCERYL-6 POLYRICINOLEATE
POLYHYDROXYSTEARIC ACID (2300 MW)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
SILICON DIOXIDE
SODIUM CHLORIDE
SODIUM HYDROXIDE
SORBITAN OLIVATE
TRIETHOXYCAPRYLYLSILANE
WATER
XANTHAN GUM
YELLOW WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 07/15/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 04/01/2022
Labeler — Obagi Cosmeceuticals LLC (790553353)
Establishment
Name Address ID/FEI Operations
G.S.COSMECEUTICAL USA, INC. 017014734 MANUFACTURE (62032-693)
Establishment
Name Address ID/FEI Operations
Denison Pharmaceuticals, LLC 001207208 MANUFACTURE (62032-693)
Establishment
Name Address ID/FEI Operations
Swiss-American CDMO, LLC 080170933 MANUFACTURE (62032-693)
Establishment
Name Address ID/FEI Operations
TENCO ASSEMBLIES, INC 075535609 PACK (62032-693)

Revised: 04/2022 Obagi Cosmeceuticals LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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