NO7 CC LIGHT- octocrylene and octinoxate emulsion NO7 CC MEDIUM- octocrylene and octinoxate emulsion

No7 CC by

Drug Labeling and Warnings

No7 CC by is a Otc medication manufactured, distributed, or labeled by Cosmetica Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%
Octocrylene 8%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

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
• reapply at least every two hours.
• use a water resistant sunscreen if swimming or sweating
• children under age 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 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

• protect the product in this container from excessive heat and direct sun

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?

1-868-75-BOOTS

SPL UNCLASSIFIED SECTION

Dist. by Boots Retail USA Inc.
Norwalk CT 06851 USA

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton - Light

No7

CC Cream
Color & Care

Moisturises
Protects
Brightens
Blurs imperfections

Sunscreen
Broad Spectrum
SPF 20

Hypo-allergenic

40 ml e 1.3 US Fl. Oz.

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton - Medium

No7

CC Cream
Color & Care

Moisturises
Protects
Brightens
Blurs imperfections

Sunscreen
Broad Spectrum
SPF 20

Hypo-allergenic

40 ml e 1.3 US Fl. Oz.

INGREDIENTS AND APPEARANCE

NO7 CC   LIGHT
octocrylene and octinoxate emulsion

Product 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 emulsion

Product 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)