FDA.reportPublic FDA data

Avobenzone, Octisalate, Octocrylene

Manufacturer
BCM Ltd | The Boots Company PLC
Effective date
2019-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:23

Label at a glance#

ProductNo7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTISALATE
Label structure11 sections

Indications and uses

Uses - helps prevent sunburn

Dosage and administration

Directions 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 protectio...

Storage and handling

Other information Protect the product in this container from excessive heat and direct sun Avoid contact with fabrics

Label contents#

Full prescribing information#

Carton Active Ingredients Section

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 8%

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 Control Center right away

Directions

INDICATIONS & USAGE SECTION

Directions

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

Avoid contact with fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), C12-15 alkyl  benzoate, Glycerin, Alcohol denat., Tribehenin, Aluminum starch octenylsuccinate, Butylene glycol, Dimethicone, Cetearyl alcohol, Cetearyl glucoside, Butyrospermum parkii (Shea) butter, Ammonium acryloydimethyltaurate/VP copolymer, Silica, Phenoxyethanol, Potassium cetyl phosphate, Methylparaben, Parfum (Fragrance), Propylene glycol, Xanthan gum, Ethylparaben, Hibiscus abelmoschus extract, Retinyl palmitate, Simethicone, Hydrolyzed hyaluronic acid, Dipropylene glycol, Hydrolyzed rice protein, Tetrasodium EDTA, Sorbitan laurate, Polysorbate 20, T-butyl alcohol, Sodium lauroyl lactylate, Phyllanthus emblica fruit extract, Carbomer, Calcium hydroxymethionine, Panax ginseng root extract, 3-aminopropane sulfonic acid, Hydroxyethylcellulose, Potassium hydroxide, Acetyl dipeptide-1 cetyl ester, Morus alba leaf extract, Ceramide NP, Ceramide AP, Sodium benzoate,  Phytosphingsine, Cholesterol, Ethylhexylglycerin, Tocopherol, Palmitoyl tripeptide-1, Palmitoyl tetrapeptide-7, Ceramide EOP, CI 77891 (Titanium dioxide), CI 77491 (Iron oxides), CI 14700 (Red 4).

Description

DESCRIPTION SECTION

RESTORE & RENEW MULTI ACTION FACE & NECK COLLECTION

25 ml e 0.84 US Fl.Oz.

The complete anti-aging skincare regime to reveal a firmer feeling, smoother, more even and younger looking face & neck in 4 weeks.

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.

New York NY 10005

www.No7beauty.com

carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartonRRMAFNMD2019frontRRMAFNMD2019front RRMAFNMD2019backRRMAFNMD2019back

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11489-144-012022-01-28C16284748780-1d6a99b39-357b-a426-e053-dadaa90af4c2No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11489-144-01No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 301 in 1 CARTONCREAM11
11489-144-01No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 3025 g in 1 TUBECREAM251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11489-144NO7 RESTORE AND RENEW FACE AND NECK MULTI ACTION DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1Legacy NDC, 2 package rows20190201_08057e2a-3b58-4e2d-861a-f36a3feea8d9.zip

Products#

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

DailyMed product names page 1 of 2 · 51 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11489-14411489-144-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 49 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
DIMETHICONE92RU3N3Y1OIACT
TRIBEHENIN8OC9U7TQZ0IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SHEA BUTTERK49155WL9YIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
PHYLLANTHUS EMBLICA FRUITYLX4CW2576IACT
XANTHAN GUMTTV12P4NEEIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
EDETATE SODIUMMP1J8420LUIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
MORUS ALBA LEAFM8YIA49Q2PIACT
CERAMIDE 34370DF050BIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CERAMIDE 6 IIF1X8L2B00JIACT
CHOLESTEROL97C5T2UQ7JIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
CERAMIDE 15THT33P7X7IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BROWN IRON OXIDE1N032N7MFOIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT

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
ad50c770-077d-445b-b635-9272f811526f08057e2a-3b58-4e2d-861a-f36a3feea8d92019-01-31WarningsExact identifier
spl id: ad50c770-077d-445b-b635-9272f811526f
spl set id: 08057e2a-3b58-4e2d-861a-f36a3feea8d9

Reported adverse events (FAERS/openFDA)#

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