Label: NO7 CC LIGHT- octocrylene and octinoxate emulsion
NO7 CC MEDIUM- octocrylene and octinoxate emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 66559-2977-2, 66559-2978-2 - Packager: Cosmetica Laboratories 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 April 2, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every two hours.
- use a water resistant sunscreen if swimming or sweating
- children under age 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 the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- Other information
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Inactive ingredients
Aqua (Water), Cetearyl alcohol, Glyceryl stearate, PEG-40 castor oil, Glycerin, Silica, Dicaprylyl carbonate, Dimethicone, Sodium potassium aluminum silicate, Butylene glycol, Phenoxyethanol, Montmorillonite, Caprylyl glycol, Tocopheryl acetate, Xanthan gum, Disodium EDTA, Tetrahexyldecyl ascorbate, Ginkgo biloba leaf extract, Panax ginseng root extract, Litchi chinensis pericarp extract, [+/- (May contain) CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77499 (Iron oxides), CI 77491 (Iron oxides).
- USA: Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton - Light
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton - Medium
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INGREDIENTS AND APPEARANCE
NO7 CC LIGHT
octocrylene and octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66559-2977 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 80 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MONTMORILLONITE (UNII: A585MN1H2L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GINKGO (UNII: 19FUJ2C58T) ASIAN GINSENG (UNII: CUQ3A77YXI) LITCHI FRUIT (UNII: Y5P61KP51E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66559-2977-2 1 in 1 CARTON 1 40 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 05/01/2014 NO7 CC MEDIUM
octocrylene and octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66559-2978 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 80 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MONTMORILLONITE (UNII: A585MN1H2L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GINKGO (UNII: 19FUJ2C58T) ASIAN GINSENG (UNII: CUQ3A77YXI) LITCHI FRUIT (UNII: Y5P61KP51E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66559-2978-2 1 in 1 CARTON 1 40 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 05/01/2014 Labeler - Cosmetica Laboratories Inc. (255080491) Establishment Name Address ID/FEI Business Operations Cosmetica Laboratories Inc. 255080491 MANUFACTURE(66559-2977, 66559-2978) , ANALYSIS(66559-2977, 66559-2978) , PACK(66559-2977, 66559-2978)
