FDA.reportPublic FDA data

Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 15

Manufacturer
BCM Ltd | The Boots Company Plc
Effective date
2012-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:34:15

Label at a glance#

ProductBotanics Hydrating Day All Bright 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

Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton labelCartonCarton

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
11489-080-012020-01-31C16284748780-19d75b9d0-eba8-f424-e053-dadaa90a57ceddaa5c2d-fefa-4da3-987c-a363e85a440d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11489-080-01Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 1550 g in 1 JARCREAM502
11489-080-01Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 151 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11489-080BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2Legacy NDC, 2 package rows20130114_ddaa5c2d-fefa-4da3-987c-a363e85a440d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTISALATEACTIVE MOIETY4X49Y0596W2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALMOND OILINACTIVE INGREDIENT66YXD4DKO92
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM2
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JO2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6R2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C402
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HIBISCUS SABDARIFFA FLOWERINACTIVE INGREDIENT45TGG6IU6M2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341L2
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GR2
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ02
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

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
11489-08011489-080-01

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
AVOBENZONEG63QQF2NOXACTIM
OCTISALATE4X49Y0596WACTIM
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
C12-15 ALKYL 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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 305 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii candidate
23 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / RECTAL11 mgExact identifier — unii candidate
23 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / OPHTHALMIC0.1 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUPPOSITORY / VAGINAL2 mgExact identifier — unii candidate
23 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
13 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINHALANT / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
88 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
DEHYDROACETIC ACIDDEHYDROACETIC ACID2KAG279R6RLOTION / TOPICAL1 mgExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAMUSCULAR28 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii candidate
23 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EXTENDED RELEASE / ORAL45 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates

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
d9325225-4f19-4cf5-92d3-f4cddcb7127cddaa5c2d-fefa-4da3-987c-a363e85a440d2012-12-20WarningsExact identifier
spl id: d9325225-4f19-4cf5-92d3-f4cddcb7127c
spl set id: ddaa5c2d-fefa-4da3-987c-a363e85a440d

Reported adverse events (FAERS/openFDA)#

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