GENTLE REJUVENATION SYSTEM- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone kit

GENTLE REJUVENATION SYSTEM by

Drug Labeling and Warnings

GENTLE REJUVENATION SYSTEM by is a Otc medication manufactured, distributed, or labeled by Obagi Medical Products, Inc., a division of Valeant Pharmaceutcals North America LLC., LABORATOIRE DR RENAUD INC., Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3%	Sunscreen
Homosalate 8%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 2.79%	Sunscreen
Oxybenzone 3%	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
• 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

ascorbic acid, citrus grandis (grapefruit) peel extract, dimethicone, dimethicone crosspolymer, fragrance, octoxynol-10

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 OMP, Inc., Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

OBAGI®

MEDICAL

GENTLE REJUVENATION SYSTEM

Sensitive Skin Kit

INGREDIENTS AND APPEARANCE

GENTLE REJUVENATION SYSTEM 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-525

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-525-91	1 in 1 CARTON; Type 0: Not a Combination Product	11/04/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	48 g

Part 1 of 1

GENTLE REJUVENATION FORTIFIED SUNSCREEN BROAD SPECTRUM SPF 30 WITH VITAMIN C 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Item Code (Source)	NDC: 62032-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.9 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)
DIMETHICONE 100 (UNII: RO266O364U)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-130-70	48 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/04/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/04/2013

Labeler - Obagi Medical Products, Inc., a division of Valeant Pharmaceutcals North America LLC. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRE DR RENAUD INC.		202501565	MANUFACTURE(62032-525) , LABEL(62032-525) , PACK(62032-525)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	MANUFACTURE(62032-525) , LABEL(62032-525) , PACK(62032-525)