FDA.reportPublic FDA data

No7 Rebalancing Day Fluid Sunscreen SPF 15

Manufacturer
BCM Ltd | The Boots Company PLC
Effective date
2010-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:28

Label at a glance#

ProductNo7 Rebalancing Day Fluid Sunscreen SPF 15
Active ingredientOCTINOXATE, AVOBENZONE, ENSULIZOLE
Label structure16 sections

Storage and handling

Other information Do not store above 30 0 C or 86 0 F

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Octinoxate (6.0%)

Avobenzone (2.0%)

Ensulizole (2.0%)

OTC - PURPOSE SECTION

Purpose

Sunscreens

Uses

  • Provides moderate protection against the adverse effects of the sun
  • Higher SPF gives more protection

WARNINGS AND PRECAUTIONS SECTION

Warnings

For external use only

When using this product

  • Keep out of eyes.  If contact occurs, rinse thoroughly with cold water.
  • Avoid direct contact with fabrics.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help.

INDICATIONS & USAGE SECTION

Directions

  • After cleansing, massage over your face and neck, avoiding contact with your eyes.
  • Apply evenly at least 15 minutes before sun exposure.
  • Reapply as required.
  • Not intended for children under the age of 12.
  • Not intended for protection while sunbathing.

STORAGE AND HANDLING SECTION

Other information

Do not store above 300C or 860F

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aqua (Water), Glycerin, Cyclopentasiloxane, Alcohol denat., Cyclohexasiloxane, C12-15 alkyl benzoate, Triethanolamine, Dimethicone, Acrylamide/ammonium acrylate copolymer, Cetyl alcohol, Myristyl myristate,  C18-36 acid glycol ester, Phenoxyethanol, Lauryl methacrylate/glycol dimethacrylate cross polymer, Polyisobutene, Glyceryl stearate, PEG-100 stearate, Betaine, Parfum (Fragrance), Dimethiconol, Methylparaben, Sodium 2-pyrrolidone-5-carboxylate, Xanthan gum, Ethylparaben, Sodium hyaluronate, Polysorbate 20, Dipropylene glycol, Sorbitol, Tetrasodium EDTA, Serine, Glycine, Glutamic acid, Lysine, BHT, Alanine, Arginine, Threonine, Propylparaben.

OTC - QUESTIONS SECTION

USA/Canada: Questions? 1-866-75-BOOTS

DESCRIPTION SECTION

Balanced Hydration...

Treat your skin to a long cool drink with this deliciously light lotion, created to work in harmony with oily to combination skin without blocking pores.

The revolutionary water-based formula vanishes in to give your skin just the amount of moisture it needs.  At the same time, the oil-absorbing micro-sponges work to reduce skin oiliness so you look youthfully radiant, not shiny.

With hyaluronic acid to keep skin hydrated for 24 hours, plus our ultra-light SPF 15 to care and protect.

After 2 weeks 68% of our testers said their skin looked healthier and more radiant.

A little facial everyday...

After cleansing, massage over your face and neck.  Apply prior to sun exposure.  Avoid direct contact with eyes.

Dermatologically tested.

INFORMATION FOR PATIENTS SECTION

Made in the UK

The Boots Company PLC Nottingham England NG2 3AA

Dist in the USA by Boots Retail USA Inc. Stamford CT06901

www.boots.com

DESCRIPTION SECTION

Bottle label

Balanced Hydration...

Treat your skin to a long cool drink with this light fluid, created for oily to combination skin without blocking pores.

The water-based formula gives your skin just the amount of moisture it needs. At the same time, the oil-absorbing micro-sponges work to reduce skin oiliness so you look youthfully radiant, not shiny.

With hyaluronic acid to keep skin hydrated for 24 hours.

After 2 weeks 68% of our testers said their skin looked healthier and more radiant.

A little facial everyday...

After cleansing, massage over your face and neck. 

Apply prior to sun exposure.

Avoid direct contact with eyes.

Dermatologically tested.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Octinoxate (6.0%)

Avobenzone (2.0%)

Ensulizole (2.0%)

INFORMATION FOR PATIENTS SECTION

Made in the UK

The Boots Company PLC Nottingham England NG2 3AA.

Dist in the USA by Boots Retail USA Inc. Stamford CT06901

USA/Canada: Questions? 1-866-75-BOOTS

www.boots.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton label

No7

Rebalancing Day Fluid

Oily/Combination

Moisturises, mattifies and balances your skin

Sunscreen SPF 15

Hypo-allergenic

Boots

100ml e 3.3 US Fl. Oz

Rebalancing Day Fluid carton.jpgRebalancing Day Fluid cartonRebalancing Day Fluid carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

No7 Rebalancing Day Fluid

Oily/Combination

Moisturises and mattifies your skin

Sunscreen SPF 15

Hypo-allergenic

Boots

100ml e 3.3 US Fl. Oz

Rebalancing Day Fluid bottle.jpgRebalancing Day Fluid bottleRebalancing Day Fluid bottle

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11489-069-012019-10-29C16284748780-1960f7f55-c07d-8e05-e053-dbdaa90a074aCarton and bottle labelling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11489-069-01No7 Rebalancing Day Fluid Sunscreen SPF 151 in 1 CARTONLOTION11
11489-069-01No7 Rebalancing Day Fluid Sunscreen SPF 15100 mL in 1 BOTTLE, PUMPLOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11489-069NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1Legacy NDC, 2 package rows20101202_c08b16e2-4e97-449a-bd9d-da3ad0158eaf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W421
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
ENSULIZOLEACTIVE MOIETY9YQ9DI1W421
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
ALANINEINACTIVE INGREDIENTOF5P57N2ZX1
ARGININEINACTIVE INGREDIENT94ZLA3W45F1
BETAINEINACTIVE INGREDIENT3SCV180C9W1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ETHYLPARABENINACTIVE INGREDIENT14255EXE391
GLUTAMIC ACIDINACTIVE INGREDIENT3KX376GY7L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
GLYCINEINACTIVE INGREDIENTTE7660XO1C1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
LYSINEINACTIVE INGREDIENTK3Z4F929H61
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
PROLINEINACTIVE INGREDIENT9DLQ4CIU6V1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SERINEINACTIVE INGREDIENT452VLY94021
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A21
SORBITOLINACTIVE INGREDIENT506T60A25R1
THREONINEINACTIVE INGREDIENT2ZD004190S1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11489-06911489-069-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
ENSULIZOLE9YQ9DI1W42ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
TROLAMINE9O3K93S3TKIACT
DIMETHICONE92RU3N3Y1OIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BETAINE3SCV180C9WIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
XANTHAN GUMTTV12P4NEEIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ETHYLPARABEN14255EXE39IACT
POLYSORBATE 207T1F30V5YHIACT
SORBITOL506T60A25RIACT
SERINE452VLY9402IACT
GLYCINETE7660XO1CIACT
GLUTAMIC ACID3KX376GY7LIACT
LYSINEK3Z4F929H6IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ALANINEOF5P57N2ZXIACT
ARGININE94ZLA3W45FIACT
THREONINE2ZD004190SIACT
PROLINE9DLQ4CIU6VIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML · Source PDF

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 8 · 478 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHELIXIR / ORAL200 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS6240 mgExact identifier — unii candidate
11 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / SUBLINGUAL0.13 mgExact identifier — unii candidate
32 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROLINEPROLINE9DLQ4CIU6VINJECTION / INTRAVENOUS0.8 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii candidate
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAVENOUS0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FINJECTION, SOLUTION / INTRAVENOUS0.29 %w/vExact identifier — unii candidate
11 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FTABLET, FILM COATED / ORAL25 mgExact identifier — unii candidate
11 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SOLUTION / ORAL14 mgExact identifier — unii candidate
4 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 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
eff82fba-618b-4299-8245-919d41d08967c08b16e2-4e97-449a-bd9d-da3ad0158eaf2010-12-02WarningsExact identifier
spl id: eff82fba-618b-4299-8245-919d41d08967
spl set id: c08b16e2-4e97-449a-bd9d-da3ad0158eaf

Reported adverse events (FAERS/openFDA)#

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