FDA.reportPublic FDA data

CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Primer

Manufacturer
Charlotte Tilbury Beauty Ltd.
Effective date
2022-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:34:33

Label at a glance#

ProductCHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Primer
Active ingredientOCTINOXATE, AVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

- helps prevent sunburn - if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally and evenly 15 minutes before sun exposure children under 6 months of age: ask a doctor reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating: - immediately after towel drying - at least every 2 hours 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...

Label contents#

Full prescribing information#

DRUG FACTS Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00%

Octinoxate 6.79%

Octisalate 4.50%

Octocrylene 2.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

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

DOSAGE & ADMINISTRATION SECTION

  • apply liberally and evenly 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating:

- immediately after towel drying

- at least every 2 hours

  • 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 am - 2pm

- wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Diethylhexyl Succinate, Glycerin, Dextrin Palmitate, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, PEG-60 Glyceryl Isostearate, Marrubium Vulgare Extract, Titanium Dioxide (CI 77891), Polyglyceryl-2 Triisostearate, Talc, Hydroxypropyl Methylcellulose Stearoxy Ether, Polysorbate 60, Sorbitan Isostearate, Agar, Tocopherol, Xanthan Gum, Iron Oxides (CI 77492), Isopropyl Titanium Triisostearate, Aluminum Hydroxide, Sodium Hyaluronate, Iron Oxides (CI 77491), Khaya Senegalensis Bark Extract, Maltodextrin, Citric Acid, BHT, Ascorbyl Glucoside, Camellia Oleifera Seed Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oil, Sodium Hydroxide, Iron Oxides (CI 77499), Plumeria Alba Flower Extract, Potassium Sorbate, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Solanum Tuberosum (Potato) Pulp Extract, Ascorbyl Dipalmitate.

Other information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Charlotte Tilbury

BROAD SPECTRUM

SPF 50

SUNSCREEN

INVISIBLE UV

FLAWLESS

PRIMER

30 mL

Outer Label - 30 mL CartonOuter Label - 30 mL CartonInner Label - 30 mL CartonInner Label - 30 mL Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70186-700-01CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Primer1 in 1 CARTONCREAM12
70186-700-01CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Primer30 mL in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70186-700CHARLOTTE TILBURY BROAD SPECTRUM SPF 50 SUNSCREEN INVISIBLE UV FLAWLESS PRIMER (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) CREAM [CHARLOTTE TILBURY BEAUTY LTD.]2Current NDC, Legacy NDC, 2 package rows20241107_d34669b8-acbc-7c93-e053-2a95a90adbe4.zip

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70186-70070186-700-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-60 GLYCERYL ISOSTEARATEWQP0973914IACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
TALC7SEV7J4R1UIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIETHYLHEXYL SUCCINATE69W9UMG3P8IACT
AGAR89T13OHQ2BIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SODIUM HYDROXIDE55X04QC32IIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
HYPROMELLOSE 2910 0.45% STEAROXY ETHERHG3GR8HU7XIACT
MALTODEXTRIN7CVR7L4A2DIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYALURONATE SODIUMYSE9PPT4THIACT
FERRIC OXIDE RED1K09F3G675IACT
SODIUM BENZOATEOJ245FE5EUIACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
ASCORBYL DIPALMITATE624RX3IESRIACT
HOREHOUNDK08036XEJVIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYGLYCERYL-2 TRIISOSTEARATE68DUY2D39AIACT
PLUMERIA ALBA FLOWERLGC8P2PC4HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ALOE VERA LEAFZY81Z83H0XIACT
POTATO PULP844I2DX0ISIACT
PENTYLENE GLYCOL50C1307PZGIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
WATER059QF0KO0RIACT
CAMELLIA OILT1PE06G0VEIACT

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
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless PrimerAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENECharlotte Tilbury Beauty Ltd.d34669b8-acbc-7c93-e053-2a95a90adbe42022-07-15WarningsExact identifier
ndc (package): 70186-700-01
ndc (product): 70186-700
ndc11 (package): 70186070001
spl id: e3ddc879-1fb7-732f-e053-2a95a90a94ce
spl set id: d34669b8-acbc-7c93-e053-2a95a90adbe4

Reported adverse events (FAERS/openFDA)#

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