NO7 ADVANCED HYDRATION DAY CREAM SUNSCREEN SPF 12- octinoxate and avobenzone cream

No7 Advanced Hydration Day Cream Sunscreen SPF 12 by

Drug Labeling and Warnings

No7 Advanced Hydration Day Cream Sunscreen SPF 12 by is a Otc medication manufactured, distributed, or labeled by Boots Retail USA Inc, The Boots Company PLC, BCM Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                      Purpose

Avobenzone (3%)                                       Sunscreens

Octinoxate (5%)

PURPOSE

• Provides moderate protection against adverse effects of the sun
• Higher SPF gives more protection
  

WARNINGS AND PRECAUTIONS

Warnings

For external use only

When using this product

Avoid contact with eyes.  If contact occurs rinse immediately with cold water.

ASK DOCTOR

Stop use and ask a doctor if rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed get medical help.

INDICATIONS & USAGE

Directions

After cleansing and toning, massage onto face and neck.

STORAGE AND HANDLING

Other information

• Do not store above 300C or 860F
  

INACTIVE INGREDIENT

Inactive ingredients

Aqua (Water), Butylene glycol, C12-15 alkyl benzoate, Glycerin, Glyceryl stearate, Cetyl alcohol, Dimethicone, Paraffinum liquidum (Mineral oil), PEG-100 stearate, C18-36 acid glycol ester, Phenoxyethanol, Mica, Carbomer, Sodium PCA, Panthenol, Methylparaben, Sodium stearoyl lactylate, Parfum (Fragrance), Potassium hydroxide, Propylparaben, Sodium lauroyl lactylate, Tetrasodium EDTA, Ceramide 3, Ceramide 6 II, Phytosphingosine, Cholesterol, BHT, Xanthan gum, Sodium hydroxide, Ceramide 1, CI 77891 (Titanium dioxide).

QUESTIONS

USA: Questions? 1-866-75-BOOTS

INFORMATION FOR PATIENTS

Mfd in the UK for BBI Ltd NG2 3AA. UK

Dist in the USA by Boots Retail USA Inc. Stamford CT 06901

DESCRIPTION

Jar label

Soften, protect and replenish moisture 24 hours a day.

Massage onto cleansed face and neck, avoiding eyes.

Hypo-allergenic     Dermatologically Tested

ACTIVE INGREDIENT

Active Ingredients

Avobenzone 3%

Octinoxate 5%

INFORMATION FOR PATIENTS

Boots

Mfd in the UK for BBI Ltd NG2 3AA. UK

Dist in the USA by Boots Retail USA Inc. Stamford CT 06901

PRINCIPAL DISPLAY PANEL

Carton label

No7 Advanced Hydration

Day Cream

24 hour moisturising care

Hypo-allergenic

Boots

50ml e 1.69 US Fl. Oz

Advanced Hydration Day Cream carton.jpg

PRINCIPAL DISPLAY PANEL

Jar label

Advanced Hydration Day Cream

Sunscreen SPF 12

50ml 1.69 US Fl. Oz

Advanced Hydration Day Cream jar.jpg

INGREDIENTS AND APPEARANCE

NO7 ADVANCED HYDRATION DAY CREAM SUNSCREEN SPF 12 
octinoxate and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68472-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 mL  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PANTHENOL (UNII: WV9CM0O67Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68472-072-01	1 in 1 CARTON
1		50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/03/2009

Labeler - Boots Retail USA Inc (143151533)

Registrant - The Boots Company PLC (218622660)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Ltd		230780322	manufacture, analysis