OBAGI SKINTRINSIQ CLARIFIYING PROTOCOL- salicylic acid, titanium dioxide, and zinc oxide kit

Obagi Skintrinsiq Clarifiying Protocol by

Drug Labeling and Warnings

Obagi Skintrinsiq Clarifiying Protocol by is a Otc medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, G.S.COSMECEUTICAL USA, INC., Denison Pharmaceuticals, LLC, Swiss-American CDMO, LLC, TENCO ASSEMBLIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Obagi ® Medical CLENZIderm M.D. ® Pore Therapy

Drug Facts

Active ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Uses

• or the treatment of acne
• dries up acne pimples
• helps prevent new acne pimples

Warnings

For external use only

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Stop use and ask a doctor if irritation becomes severe.

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

Directions

• Cleanse the skin thoroughly before applying this product.
• Shake product well before use.
• Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

• store away from heat and direct sunlight
• store at controlled room temperature: 15°–25°C (59°–77°F)

Inactive ingredients

benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

Questions or comments?

1.800.636.7546 Monday–Friday 9a.m.–4p.m. Pacific Time

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

SPL UNCLASSIFIED SECTION

Obagi™ Sun Shield Mineral Broad Spectrum SPF 50 Sunscreen

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium dioxide 6.2%	Sunscreen
Zinc oxide 15.6%	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

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs

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

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

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

Questions or comments?

1.800.636.7546

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

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

SKINTRINSIQ™

CLARIFYING
PROTOCOL KIT

INCLUDES:

• 60 Tips
• Obagi Nu-Derm ® Gentle Cleanser, 2 FL. OZ.
• Obagi Nu-Derm ® Toner, 2 FL. OZ.
• CLENZIderm M.D. ® Pore Therapy, 5 FL. OZ.
• Obagi Hydrate ® Facial Moisturizer, 1.7 OZ.
• Obagi Sun Shield™ Mineral Broad Spectrum SPF 50 Sunscreen, 3 OZ.

OBAGI ®

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

OBAGI ®
MEDICAL

CLENZIderm M.D. ®

Pore Therapy

Salicylic Acid 2%
Acne Treatment

5 FL. OZ. (148 mL)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

OBAGI™
MEDICAL

Sun Shield
Broad
Spectrum
SPF 50

MINERAL

Sunscreen
Lotion

PA++++
Non-comedogenic
Dermatologist Tested

Net wt. 3 oz. (85 g)

INGREDIENTS AND APPEARANCE

OBAGI SKINTRINSIQ CLARIFIYING PROTOCOL 
salicylic acid, titanium dioxide, and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-909

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-909-09	1 in 1 BOX	08/01/2021

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, PLASTIC	148 mL
Part 4	1 BOTTLE, PUMP	48 g
Part 5	1 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 Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	APRICOT KERNEL OIL (UNII: 54JB35T06A)
INGR	BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	GLYCERETH-7 (UNII: 3D2Y91QZ2H)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	OLEYL LACTATE (UNII: B3AWW0N3GM)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	SAGE (UNII: 065C5D077J)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/01/2021

Part 2 of 5

OBAGI NU-DERM TONER 
face and neck (excluding shaving preparations) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	DMDM HYDANTOIN (UNII: BYR0546TOW)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	POLYSORBATE 80 (UNII: 6OZP39ZG8H)
INGR	POTASSIUM ALUM (UNII: 1L24V9R23S)
INGR	SAGE (UNII: 065C5D077J)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/01/2021

Part 3 of 5

CLENZIDERM PORE THERAPY  ACNE TREATMENT
salicylic acid liquid

Product Information
Item Code (Source)	NDC: 62032-612
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHAMOMILE (UNII: FGL3685T2X)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-612-04	148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	08/01/2021

Part 4 of 5

OBAGI HYDRATE FACIAL MOISTURIZER 
moisturizing lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	LAURETH-12 (UNII: OAH19558U1)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SACCHARIDE ISOMERATE (UNII: W8K377W98I)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
INGR	SOY STEROL (UNII: PL360EPO9J)
INGR	SOYBEAN (UNII: L7HT8F1ZOD)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		48 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/01/2021

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-811-09	1 in 1 CARTON
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	08/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	08/01/2021

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
G.S.COSMECEUTICAL USA, INC.		017014734	manufacture(62032-909)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(62032-909)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(62032-909)

Establishment
Name	Address	ID/FEI	Business Operations
TENCO ASSEMBLIES, INC		075535609	pack(62032-909)