Drug Facts

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

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

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, Dimethicone

Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

Way to
Glow
Defend, Hydrate & Protect

OBAGI®
MEDICAL Kit Carton

OBAGI MEDICAL WAY TO GLOW KIT
homosalate, octisalate, and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62032-690

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62032-690-02	1 in 1 CARTON	03/20/2023
1		1 in 1 BAG; Type 0: Not a Combination Product

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	28 g
Part 2	1 BOTTLE, DROPPER	30 mL
Part 3	1 BOTTLE, PUMP	48 g

Part 1 of 3

SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
homosalate, octisalate, and zinc oxide lotion

Product Information
Item Code (Source)	NDC:62032-140
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	165 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
C15-19 ALKANE (UNII: CI87N1IM01)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CANDELILLA WAX (UNII: WL0328HX19)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62032-140-05	28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	03/20/2023

Part 2 of 3

OBAGI MEDICAL PROFESSIONAL-C SERUM 15
face and neck (excluding shaving preparations) liquid

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	WATER (UNII: 059QF0KO0R)
INGR	EVERNIA PRUNASTRI (UNII: O3034Q5AHK)
INGR	GRAPEFRUIT PEEL (UNII: 3582N05Q44)
INGR	ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
INGR	PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		03/20/2023

Part 3 of 3

OBAGI MEDICAL OBAGI HYDRATE FACIAL MOISTURIZER
moisturizing lotion

Product Information
Route of Administration	TOPICAL

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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		03/20/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	03/20/2023

Labeler - Obagi Cosmeceuticals LLC (790553353)

Name	Address	ID/FEI	Business Operations
Establishment
G.S.COSMECEUTICAL USA, INC.		017014734	manufacture(62032-690)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, LLC		001207208	manufacture(62032-690)

Name	Address	ID/FEI	Business Operations
Establishment
Swiss-American CDMO, LLC		080170933	manufacture(62032-690)

Name	Address	ID/FEI	Business Operations
Establishment
Identipak, Inc.		942862350	pack(62032-690)

Obagi Medical Way to Glow Kit

Uses

Warnings

Directions

Inactive Ingredients

PRINCIPAL DISPLAY PANEL - Kit Carton