FDA.reportPublic FDA data

Botanics All Bright Hydrating Day Cream Sunscreen Broad Spectrum SPF 15

Manufacturer
BCM Ltd | The Boots Company Plc
Effective date
2016-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:39

Label at a glance#

ProductBotanics All Bright Hydrating Day Cream Sunscreen Broad Spectrum SPF 15
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure15 sections

Indications and uses

Uses - helps prevent sunburn.

Dosage and administration

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 o...

Storage and handling

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

Label contents#

Full prescribing information#

Carton Active Ingredients Section

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Avobenzone 3%

Octisalate 3%

Octocrylene 5%

Purpose Sunscreen

Uses

OTC - PURPOSE SECTION

Uses - helps prevent sunburn.

Warnings

WARNINGS AND PRECAUTIONS SECTION

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

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

DESCRIPTION SECTION

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

INFORMATION FOR PATIENTS SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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

Description

DESCRIPTION SECTION

Directions: Use every morning after cleansing

Information

INFORMATION FOR PATIENTS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartonAllBrightDayCreamAllBrightDayCream

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11489-093-012025-01-30C16284748780-12cef2736-b346-d83d-e063-dadaa90ab31f15ad7623-3b8b-485c-a689-5f2bd1a7fecb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11489-093-01Botanics All Bright Hydrating Day Cream Sunscreen Broad Spectrum SPF 1550 g in 1 JARCREAM501
11489-093-01Botanics All Bright Hydrating Day Cream Sunscreen Broad Spectrum SPF 151 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11489-093BOTANICS ALL BRIGHT HYDRATING DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1Legacy NDC, 2 package rows20160729_15ad7623-3b8b-485c-a689-5f2bd1a7fecb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11489-09311489-093-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
CETEARYL OLIVATE58B69Q84JOIACT
TRIBEHENIN8OC9U7TQZ0IACT
SHEA BUTTERK49155WL9YIACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SORBITAN OLIVATEMDL271E3GRIACT
ALMOND OIL66YXD4DKO9IACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIPROPYLENE GLYCOLE107L85C40IACT
EDETATE SODIUMMP1J8420LUIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZOIC ACID8SKN0B0MIMIACT
DEHYDROACETIC ACID2KAG279R6RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
978eb2f0-0c94-4a17-a481-c2af89423c8e15ad7623-3b8b-485c-a689-5f2bd1a7fecb2016-06-30WarningsExact identifier
spl id: 978eb2f0-0c94-4a17-a481-c2af89423c8e
spl set id: 15ad7623-3b8b-485c-a689-5f2bd1a7fecb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.