ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN- titanium dioxide and zinc oxide lotion

ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by OMP, Inc., Swiss-American Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 2.0%	Sunscreen
Zinc Oxide 15.5%	Sunscreen

Uses

• helps prevent sunburn

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

alumina, butylparaben, C12-15 alkyl benzoate, cetearyl alcohol, coco-glucoside, dipropylene glycol, ethylparaben, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, iron oxides, isobutylparaben, isohexadecane, isopropyl titanium triisostearate/triethoxycaprylylsilane crosspolymer, methylparaben, mica, PEG-6, phenoxyethanol, polyhydroxystearic acid, propylparaben, titanium dioxide, tocopheryl acetate, triethoxycaprylylsilane, water

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

Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies.

Distributed by OMP, Inc., Long Beach, CA 90806

©2013 Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC.

www.obagi.com
Made in USA

10726414Z 7264
Rev. 12/13

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

OBAGI®
MEDICAL

rosaclear®

∙ NON-COMEDOGENIC ∙ NON-COMEDOGENIC

SKIN BALANCING
SUN PROTECTION
BROAD SPECTRUM SPF 30
SUNSCREEN LOTION

Net wt. 3 oz. (85 g)

INGREDIENTS AND APPEARANCE

ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30   SUNCREEN
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	155 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALUMINUM OXIDE (UNII: LMI26O6933)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOHEXADECANE (UNII: 918X1OUF1E)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	GRAY	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-072-64	88 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2009

Labeler - OMP, Inc. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American Products		611921669	MANUFACTURE(62032-072)