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

ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30 by

Drug Labeling and Warnings

ROSACLEAR SKIN BALANCING SUN PROTECTION 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
• higher SPF gives more sunburn protection.

Warnings

For external use only.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally before sun exposure and as needed.
• children under 6 months of age: ask a doctor.
• reapply as needed or after towel drying, swimming, or sweating.

Other information

• store at controlled room temperature: 15-25°C (59-77°F).
• Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Inactive ingredients

Alumina, Butylparaben, Cetearyl Alcohol, Coco-Glucoside, C12-15 Alkyl Benzoate, Dipropylene Glycol, PEG-6, Ethylparaben, Glycerin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Isobutylparaben, Isohexadecane, Isopropyl Titanium Triisostearate/Triethoxycaprylylsilane Crosspolymer, Methylparaben, Mica, Phenoxyethanol, Polyhydroxystearic Acid, Propylparaben,Tocopheryl Acetate, Triethoxycaprylylsilane, Water.

SPL UNCLASSIFIED SECTION

Dist. by OMP, Inc.
3760 Kilroy Airport Way Suite 500
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

OBAGI®
MEDICAL

rosaclear®
system

∙ NON-COMEDOGENIC ∙ NON-COMEDOGENIC

SKIN BALANCING
SUN PROTECTION
SPF 30
SUNSCREEN LOTION

3 FL.OZ. (88 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-103
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: 62032-103-90	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(62032-103)