PROFESSIONAL-C SUNCARE BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Professional-C Suncare Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Professional-C Suncare Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Obagi Cosmeceuticals, 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 - 48 g Tube Carton

OBAGI®
MEDICAL

Professional-C™

SUNCARE

BROAD SPECTRUM
SPF 30

SUNSCREEN

Net wt. 1.7 oz. (48 g)

INGREDIENTS AND APPEARANCE

PROFESSIONAL-C SUNCARE BROAD SPECTRUM SPF 30  SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-050
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)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-050-54	1 in 1 CARTON	01/02/2014
1		48 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	part352	01/02/2014

Labeler - Obagi Cosmeceuticals (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	MANUFACTURE(62032-050) , LABEL(62032-050) , PACK(62032-050)