SPL v2
SPL
SPL Set ID 0d4986d4-a429-4a97-9d23-6a903e167cda
Route
TOPICAL
Published
Effective Date 2012-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.5 g) Octisalate (2.5 g) Octocrylene
Inactive Ingredients
Water Glycerin Dimethicone Cetearyl Glucoside Isostearyl Isostearate Tribehenin Shea Butter Propylene Glycol Cetostearyl Alcohol Sodium Polyacrylate (8000 Mw) Potassium Cetyl Phosphate Phenoxyethanol Caprylyl Glycol Citric Acid Monohydrate Dipropylene Glycol Sodium Benzoate Ethylhexylglycerin Potassium Sorbate Edetate Sodium Sorbitol Tilia Cordata Flower Althaea Officinalis Root .alpha.-tocopherol Acetate Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-01-14

Description

Active Ingredients Avobenzone 3% Octisalate 3% Octocrylene 5% Purpose Sunscreen


Medication Information

Description

Immediately calms sensitive skin and with continued use reduces skin reactivity.

Active plant extract, Marshmallow, contains natural sugars and polyphenols to help calm skin and leave it less sensitive.

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

Uses

Uses - helps prevent sunburn.

Carton

Carton label

Storage

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

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

Jar Label

Boots Botanics The Power of Plants

Skin Calming Day Cream Sunscreen Broad Spectrum SPF 15

50ml e 1.69 US Fl. Oz.

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

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

Information

Made in the UK.

The Boots Company PLC Nottingham England NG2 3AA

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

www.boots.com

Ask A Doctor

Stop use and ask a doctor if rash occurs.

Inactive Ingredients

Aqua (Water), C12-15 alkyl benzoate, Glycerin, Dimethicone, Cetearyl glucoside, Isostearyl isostearate, Tribehenin, Butyrospermum parkii (Shea) butter, Propylene glycol, Cetearyl alcohol, Sodium polyacrylate, Potassium cetyl phosphate, Phenoxyethanol, Dimethicone crosspolymer, Caprylyl glycol, Parfum (Fragrance), Citric acid, Dipropylene glycol, Sodium benzoate, Acrylates/vinyl isodecanoate crosspolymer, Ethylhexylglycerin, Potassium sorbate, Tetrasodium EDTA, Sorbitol, Tilia cordata flower extract, Althaea officinalis root extract, Tocopheryl acetate, Silica

Keep Out of Reach of Children

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

Carton Active Ingredients Section

Active Ingredients

Avobenzone 3%

Octisalate 3%

Octocrylene 5%

Purpose Sunscreen


Structured Label Content

Uses

Uses - helps prevent sunburn.

Carton

Carton label

Storage

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

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

Jar Label (Jar label)

Boots Botanics The Power of Plants

Skin Calming Day Cream Sunscreen Broad Spectrum SPF 15

50ml e 1.69 US Fl. Oz.

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

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

Description

Immediately calms sensitive skin and with continued use reduces skin reactivity.

Active plant extract, Marshmallow, contains natural sugars and polyphenols to help calm skin and leave it less sensitive.

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 Retail USA Inc. Norwalk CT 06851 USA

www.boots.com

Ask A Doctor (Ask a doctor)

Stop use and ask a doctor if rash occurs.

Inactive Ingredients (Inactive ingredients)

Aqua (Water), C12-15 alkyl benzoate, Glycerin, Dimethicone, Cetearyl glucoside, Isostearyl isostearate, Tribehenin, Butyrospermum parkii (Shea) butter, Propylene glycol, Cetearyl alcohol, Sodium polyacrylate, Potassium cetyl phosphate, Phenoxyethanol, Dimethicone crosspolymer, Caprylyl glycol, Parfum (Fragrance), Citric acid, Dipropylene glycol, Sodium benzoate, Acrylates/vinyl isodecanoate crosspolymer, Ethylhexylglycerin, Potassium sorbate, Tetrasodium EDTA, Sorbitol, Tilia cordata flower extract, Althaea officinalis root extract, Tocopheryl acetate, Silica

Keep Out of Reach of Children (Keep out of reach of children)

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

Carton Active Ingredients Section

Active Ingredients

Avobenzone 3%

Octisalate 3%

Octocrylene 5%

Purpose Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)