BOTANICS TRIPLE ACTION DAY MOISTURE CREAM SUNSCREEN SPF 15- octinoxate and avobenzone cream

BOTANICS TRIPLE ACTION DAY MOISTURE CREAM SUNSCREEN SPF 15 by

Drug Labeling and Warnings

BOTANICS TRIPLE ACTION DAY MOISTURE CREAM SUNSCREEN SPF 15 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 3.0%               Sunscreens

Octinoxate 4.5%

PURPOSE

Uses

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

WARNINGS AND PRECAUTIONS

Warnings

For external use only

When using this product keep out of eyes.  If contact occurs rinse thoroughly with cold water.  Avoid direct contact with fabric.

HOW SUPPLIED

Colour may vary due to natural extracts

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

• Massage onto face and neck with gentle upward strokes.
• Apply evenly at least 15 minutes before sun exposure.
• Reapply as required.
• Not intended for children under the age of 12.
• Not intended for protection while sunbathing.
  

STORAGE AND HANDLING

Other Information

Do not store above 300C or 860F

INACTIVE INGREDIENT

Inactive Ingredients

Aqua (Water), C12-15 alkyl benzoate, Butylene glycol, Dimethicone, Polyglyceryl-3 methylglucose distearate, C18-36 acid glycol ester, Butyrospermum parkii (Shea butter), Aesculus hippocastanum (Horsechestnut) extract, Theobroma cacao (Cocoa) seed butter, Phenoxyethanol, VP/hexadecene copolymer, Sodium benzoate, Parfum (Fragrance), Methylparaben, Acrylates/vinyl isodecanoate crosspolymer, Tetrasodium EDTA, Butylparaben, Ethylparaben, Potassium hydroxide, Maltodextrin, Propylparaben, Isobutylparaben, Dipropylene glycol, Silica, BHT

QUESTIONS

Questions? 1-866-75-BOOTS

DESCRIPTION

Plant extracts at levels that really work, combined and formulated for outstanding product performance.  Naturally.

A triple action formulation for a complete daily skincare routine: moisturises, protects and promotes healthy looking skin.  Horsechestnut extract a powerful anti-oxidant and SPF15 help protect against premature skin ageing.

Dermatologically tested.

INFORMATION FOR PATIENTS

Mfd in the U.K. for BBI NG2 3AA. UK.

Dist in the USA by Boots Retail USA Inc.

Stamford CT 06901

www.boots.com

PRINCIPAL DISPLAY PANEL

Carton label

Normal/Dry Skin

Triple Action Day Moisture Cream Sunscreen SPF 15

PEAU NORMALE ET SECHE

Crème Hydratante de Jour ā Triple Action FPS 15

Boots

The Power of Plants

BOTANICS

50ml e 1.69 US Fl. Oz

TA Day Moisture Cream carton.jpg

PRINCIPAL DISPLAY PANEL

Jar front label

Triple Action Day Moisture Cream Sunscreen SPF 15

Horsechestnut protects

Crème Solaire Hydratante de Jour ā Triple Action FPS 15

Le Marronnier d'Inde protège

Boots

The Power of Plants

BOTANICS

50ml e 1.69 US Fl. Oz

TA Day Moisture Cream front label.jpg

PRINCIPAL DISPLAY PANEL

Jar back label

Dermatologically tested

WARNINGS: Avoid getting directly in eyes.  If contact occurs rinse thoroughly with cold water.  Avoid direct contact with fabric.  Colour may vary due to natural extracts.

Dermo-teste

MISE EN GARDE: Éviter tout contact avec les yeux.  En cas de projection, rincer immédiatement ā l'eau froide.  Éviter tout contact direct avec du tissu.  La couleur peut varier en raison des extraits naturels.

ACTIVE INGREDIENTS/ACTIFS: Avobenzone 3.0%  Octinoxate 4.5%

Mdf in the U.K. for/Fabriqué au R.-U. pour BBI NG2 3AA. UK.

Dist in the USA by/aux É.-U. par Boots Retail USA Inc. Stamford CT 06901

USA/Canada: Questions? 1-866-75-BOOTS

www.boots.com

TA Day Moisture Cream back label.jpg

INGREDIENTS AND APPEARANCE

BOTANICS TRIPLE ACTION DAY MOISTURE CREAM SUNSCREEN SPF 15 
octinoxate and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68472-099
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.25 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)
DIMETHICONE (UNII: 92RU3N3Y1O)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
COCOA BUTTER (UNII: 512OYT1CRR)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68472-099-01	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	01/20/2010

Labeler - Boots Retail USA Inc (143151533)

Registrant - The Boots Company PLC (218622660)

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