BOTANICS DAY MOISTURE SUNSCREEN SPF 12- octinoxate, avobenzone and octisalate cream

Botanics Day Moisture Sunscreen SPF 12 by

Drug Labeling and Warnings

Botanics Day Moisture 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

BOTANICS DAY MOISTURE CREAM SUNSCREEN SPF 12

Active Ingredients      Purpose

Avobenzone 3%            Sunscreens
Octinoxate 7.5%
Octisalate 2.5%

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.
Rinse with water to remove.

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

• Gently massage onto face and neck.
• 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), Glycerin, Butylene glycol, Caprylic/capric triglyceride, PPG-15 stearyl ether, Dimethicone, Steareth-21, Mel (Honey), Cetyl alcohol, Steareth-2, Polyacrylamide, Phenoxyethanol, C13-14 isoparaffin, Hydrolyzed rice bran protein, Methylparaben, Parfum (Fragrance), Sodium benzoate, Laureth-7, Propylparaben, Citric acid, Sodium chloride, Tetrasodium EDTA, Linalool, Benzyl salicylate, BHT, Sodium citrate, Hexyl cinnamal, Limonene, Hydroxycitronellal, Citronellol, Geraniol, Dipropylene glycol, Apha-isomethyl ionone, Ethylparaben, Butylparaben, Isobutylparaben, CI 19140 (Yellow 5).

QUESTIONS

USA Questions?1-866-75-BOOTS

DESCRIPTION

Plant extracts at levels that really work.

This rich, indulgent cream instantly hydrates then continues to top up the skin's natural moisture level for up to 12 hours. With honey and rice extract to restore, plump and smooth your skin. With UVA/UVB SPF12 protection to target skin ageing.

Dermatologically tested

INFORMATION FOR PATIENTS

Mfd in the UK for Boots Beauty International Limited

NG2 3AA. UK

Dist in the USA by Boots Retail USA Inc.

Stamford CT 06901

USA: Questions? 1-866-75-BOOTS

www.boots.com

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 2.5%.

INACTIVE INGREDIENT

IN-ACTIVE INGREDIENTS: Aqua (Water), Glycerin, Butylene glycol, Caprylic/capric triglyceride, PPG-15 stearyl ether, Dimethicone, Steareth-21, Mel (Honey), Cetyl alcohol, Steareth-2, Polyacrylamide, Phenoxyethanol, C13-14 isoparaffin, Hydrolyzed rice bran protein, Methylparaben, Parfum (Fragrance), Sodium benzoate, Laureth-7, Propylparaben, Citric acid, Sodium chloride, Tetrasodium EDTA, Linalool, Benzyl salicylate, BHT, Sodium citrate, Hexyl cinnamal, Limonene, Hydroxycitronellal, Citronellol, Geraniol, Dipropylene glycol, Alpha-isomethyl ionone, Ethylparaben, Butylparaben, Isobutylparaben, CI 19140 (Yellow 5).

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

USA: Questions? 1-866-75-BOOTS www.boots.com

DESCRIPTION

Plant extracts at levels that really work.

This rich, indulgent cream instantly hydrates then continues to top up the skin's natural moisture level for up to 12 hours. With honey and rice extract to restore, plump and smooth your skin. With UVA/UVB SPF12 protection to target premature skin ageing.

Dermatologically tested.

INDICATIONS & USAGE

Directions: Use daily, alone or under make up, following your cleansing routine. Massage onto skin using upward strokes.

Colour may vary due to natural extracts.

WARNINGS AND PRECAUTIONS

Warnings: Avoid contact with eyes. May cause irritation.

If contact occurs, rinse immediately with cold water.

If irritation persists, consult your physician immediately.

Avoid direct contact with fabric.

PRINCIPAL DISPLAY PANEL

The Power of Plants

BOTANICS

DAY MOISTURE CREAM

Sunscreen SPF 12

With hydrating rice extract and honey to

restore, plump and smooth your skin.

50ml e 1.69 US Fl. Oz.

PRINCIPAL DISPLAY PANEL

The Power of Plants

BOTANICS

DAY MOISTURE CREAM

Sunscreen SPF 12

With hydrating rice extract and honey.

50ml e 1.69 US Fl. Oz.

HOW SUPPLIED

Colour may vary due to natural extracts.

INGREDIENTS AND APPEARANCE

BOTANICS DAY MOISTURE SUNSCREEN SPF 12 
octinoxate, avobenzone and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68472-074
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 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 mL  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.25 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HONEY (UNII: Y9H1V576FH)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
RICE BRAN (UNII: R60QEP13IC)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68472-074-01	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	02/25/2010

Labeler - Boots Retail USA Inc (143151533)

Registrant - The Boots Company PLC (218622660)

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