NDC | 62032-072-64 |
Set ID | affadfae-ce06-42b6-a044-ee621d6ea727 |
Category | HUMAN OTC DRUG LABEL |
Packager | OMP, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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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
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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
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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
- Questions or comments?
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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 USA10726414Z 7264
Rev. 12/13 - PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
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INGREDIENTS AND APPEARANCE
ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN
titanium dioxide and zinc oxide lotionProduct 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)