BOTANICS COMPLEXION REFINING DAY MOISTURE LOTION SUNSCREEN SPF 12- octinoxate and avobenzone lotion

Botanics Complexion Refining Day Moisture Lotion Sunscreen SPF 12 by

Drug Labeling and Warnings

Botanics Complexion Refining Day Moisture Lotion 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

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 30oC or 86oF.

INACTIVE INGREDIENT

Inactive ingredients

Aqua (Water), C12-15 alkyl benzoate, Butylene glycol, Dimethicone, Glycerin, Sorbitan stearate, Cetyl alcohol, C18-36 acid glycol ester, Kaolin, Rosmarinus officinalis (Rosemary) leaf extract, Phenoxyethanol, Butyrospermum parkii (Shea butter), Lauryl methacrylate/glycol dimethacrylate cross polymer, Methylparaben, Carbomer, Propylparaben, Sucrose cocoate, Xanthan gum, Limonene, Parfum (Fragrance), Potassium hydroxide, Butylparaben, Ethylparaben, Linalool, Tetrasodium EDTA, Isobutylparaben, Dipropylene glycol, Citronellol, Zinc chloride, BHT, Tetrasodium pyrophosphate, Cinnamyl alcohol, Citral

QUESTIONS

USA: Questions? 1-866-75-BOOTS

DESCRIPTION

ACTIVE PLANT EXTRACTS

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

Naturally.

Ideal for Blemish Prone Skin

Skin needs moisture, but too much oil can clog pores and lead to blemishes.  This light lotion hydrates and helps to soothe the skin while oil absorbing powders help to reduce shine. 

Oil Free. Non-pore blocking.

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

DESCRIPTION

Tube label

ACTIVE PLANT EXTRACTS

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

This light lotion hydrates and soothes the skin while oil absorbing powders help to reduce shine. 

Oil free.  Non-pore blocking.  SPF 12.

Dermatologically tested.

EXTRAITS ACTIFS DE PLANTES

Des extraits de plantes à des degrés efficaces, agencés et formulés pour un produit d'une performance exceptionnelle. Tout naturellement.

Cette lotion légère hydrate et aide à adoucir la peau pendant que les poudres absorbantes contribuent à réduire le lustre. 

Sans huile.  N'obstrue pas les pores.  FPS 12.

Dermo-testé

INDICATIONS & USAGE

DIRECTIONS: Massage onto face and neck using gentle upward strokes.

MODE D'EMPLOI: Massez sur le visage et le cou en suivant des mouvements ascendants.

ACTIVE INGREDIENT

Active ingredients: Avobenzone 3.0%, Octinoxate 5.0%

WARNINGS AND PRECAUTIONS

WARNINGS: Avoid getting directly in eyes.  If contact occurs rinse thoroughly with cold water.  Avoid direct contact with fabric.

MISE EN GARDE: Éviter tout contact avec les yeux.  En cas de projection, rincer immédiatement à l'eau froide.  Éviter tout contact direct avec du tissu.

HOW SUPPLIED

Colour may vary due to natural extracts.

La couleur peut varier en raison des extraits naturels.

INFORMATION FOR PATIENTS

EXTRACTS AUTHENTICATED BY ROYAL BOTANIC GARDENS KEW

EXTRAITS APPROUVES PAR LES JARDINS BOTANIQUES ROYAUX DE KEW

Mfd 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

PRINCIPAL DISPLAY PANEL

Carton label

COMPLEXION REFINING

Day Moisture Lotion Sunscreen SPF 12

Rosemary protects and clarifies

AFFINAGE DU TEINT

Lotion Hydratante Jour FPS12

Le Romarin protège et éclaircit

BOOTS

The Power of Plants

BOTANICS

75ml e 2.5 US Fl. Oz

CR Day Moisture Lotion carton.jpg

PRINCIPAL DISPLAY PANEL

Day Moisture Lotion Sunscreen SPF 12

Rosemary protects and clarifies

Lotion Hydratante Jouse FPS12

Le Romarin protège et éclaircit

Boots

The Power of Plants

BOTANICS

75ml e 2.5 US Fl. Oz

CR Day Moisture Lotion label.jpg

INGREDIENTS AND APPEARANCE

BOTANICS COMPLEXION REFINING DAY MOISTURE LOTION SUNSCREEN SPF 12 
octinoxate and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68472-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 mL  in 75 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2.25 mL  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Dimethicone (UNII: 92RU3N3Y1O)
Glycerin (UNII: PDC6A3C0OX)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Cetyl Alcohol (UNII: 936JST6JCN)
Kaolin (UNII: 24H4NWX5CO)
Rosemary (UNII: IJ67X351P9)
Phenoxyethanol (UNII: HIE492ZZ3T)
Shea Butter (UNII: K49155WL9Y)
Methylparaben (UNII: A2I8C7HI9T)
Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)
Propylparaben (UNII: Z8IX2SC1OH)
Xanthan Gum (UNII: TTV12P4NEE)
Potassium Hydroxide (UNII: WZH3C48M4T)
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Isobutylparaben (UNII: 0QQJ25X58G)
Zinc Chloride (UNII: 86Q357L16B)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Sodium Pyrophosphate (UNII: O352864B8Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68472-028-01	1 in 1 CARTON
1		75 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/27/2010

Labeler - Boots Retail USA Inc (143151533)

Registrant - The Boots Company PLC (218622660)

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