BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene cream

Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by BCM Ltd, The Boots Company Plc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Carton Active Ingredients Section

Active Ingredients

Avobenzone 3%

Octisalate 3%

Octocrylene 5%

Purpose Sunscreen

Uses

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

Ask a doctor

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Centre right away.

Directions

Directions for sunscreen use

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

children under 6 months of age: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

Storage

Other information - protect the product in this container from excessive heat and direct sun

Inactive ingredients

Aqua (Water), C12-15 alkyl benzoate, Glycerin, Dimethicone, Cetearyl olivate, Tribehenin, Butyrospermum parkii (Shea) butter, Hibiscus sabdariffa flower extract, Cetearyl alcohol, Sorbitan olivate, Alcohol denat., Prunus amygdalus dulcis (Sweet almond) oil, Sodium polyacrylate, Phenoxyethanol, Dimethicone crosspolymer, Parfum (Fragrance), Caprylyl glycol, Xanthan gum, Citric acid,
Sodium benzoate, Sodium hyaluronate, Ethylhexylglycerin, Dipropylene glycol, Tetrasodium EDTA, Potassium hydroxide, Tocopheryl acetate, Benzoic acid, Dehydroacetic acid

Description

Formulated with hyaluronic acid to instantly boost moisture levels.

Active plant extract, Hibiscus, contains natural AHAs which mildly exfoliate to help leave skin smoother and brighter.

Directions: Use every morning after cleansing. Colour may vary due to natural ingredients. Formulated without parabens.

Information

Made in the UK.

The Boots Company PLC Nottingham England NG2 3AA

Dist. in the USA by Boots Retain USA Inc. Norwalk CT 06851 USA

www.boots.com

Jar label

Boots Botanics The Power of Plants

Hydrating Day Cream Sunscreen Broad Spectrum SPF 15

50ml e 1.69 US Fl. Oz.

Active ingredients: Avobenzone 3%, Octisalate 3%, Octocrylene 5%

Warnings

Avoid contact with eyes. If product gets into the eyes, rinse well with water immediately.

Description

Directions: Use every morning after cleansing

Information

The Boots Company PLC

Notingham England NG2 3AA

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

Made in the UK

www.boots.com

Carton

Carton label

INGREDIENTS AND APPEARANCE

BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11489-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.5 g  in 50 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEA BUTTER (UNII: K49155WL9Y)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ALMOND OIL (UNII: 66YXD4DKO9)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE SODIUM (UNII: MP1J8420LU)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11489-080-01	1 in 1 CARTON
1		50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/14/2013

Labeler - BCM Ltd (230780322)

Registrant - The Boots Company Plc (218622660)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Ltd		230780322	manufacture(11489-080) , analysis(11489-080)