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

Obagi Medical Way to Glow Kit by

Drug Labeling and Warnings

Obagi Medical Way to Glow Kit 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, Identipak, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

PURPOSE

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

• 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

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

Way to
Glow
Defend, Hydrate & Protect

OBAGI®
MEDICAL

INGREDIENTS AND APPEARANCE

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-140-05	28 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	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

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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)

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

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

Part 3 of 3

OBAGI MEDICAL OBAGI HYDRATE FACIAL MOISTURIZER 
moisturizing lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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)

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		03/20/2023

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

Labeler - Obagi Cosmeceuticals LLC (790553353)

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

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

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

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