Label: ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN- titanium dioxide and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62032-072-64 - Packager: OMP, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 10, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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
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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)