SPL v1
SPL
SPL Set ID 15ad7623-3b8b-485c-a689-5f2bd1a7fecb
Route
TOPICAL
Published
Effective Date 2016-07-29
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 Alkyl (c12-15) Benzoate Glycerin Dimethicone Cetearyl Olivate Tribehenin Shea Butter Hibiscus Sabdariffa Flower Cetostearyl Alcohol Sorbitan Olivate Almond Oil Sodium Polyacrylate (8000 Mw) Phenoxyethanol Caprylyl Glycol Xanthan Gum Citric Acid Monohydrate Sodium Benzoate Hyaluronate Sodium Ethylhexylglycerin Dipropylene Glycol Edetate Sodium Potassium Hydroxide .alpha.-tocopherol Acetate Benzoic Acid Dehydroacetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-06-30

Description

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


Medication Information

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.

Uses

Uses - helps prevent sunburn.

Section 51945-4

carton

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

Hydrating 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 Retain 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 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

Keep Out of Reach of Children

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

Section 51945-4 (51945-4)

carton

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

Hydrating 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

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

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 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

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 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)