CHARLOTTE TILBURY BROAD SPECTRUM SPF 50 SUNSCREEN INVISIBLE UV FLAWLESS PRIMER- avobenzone, octinoxate, octisalate, octocrylene cream 
Charlotte Tilbury Beauty Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Primer

DRUG FACTS
Active ingredients

Avobenzone 3.00%

Octinoxate 6.79%

Octisalate 4.50%

Octocrylene 2.00%

Purpose

Sunscreen

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

Warnings

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.

Stop use and ask a doctor if rash occurs.

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

Directions

- immediately after towel drying

- at least every 2 hours

- limit time in the sun, especially from 10 am - 2pm

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

Inactive ingredients

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

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

Charlotte Tilbury

BROAD SPECTRUM

SPF 50

SUNSCREEN

INVISIBLE UV

FLAWLESS

PRIMER

30 mL

Outer Label - 30 mL CartonInner Label - 30 mL Carton

CHARLOTTE TILBURY BROAD SPECTRUM SPF 50 SUNSCREEN INVISIBLE UV FLAWLESS PRIMER 
avobenzone, octinoxate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70186-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.038 g  in 30 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.918 g  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.377 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.612 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TALC (UNII: 7SEV7J4R1U)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
AGAR (UNII: 89T13OHQ2B)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE 2910 0.45% STEAROXY ETHER (UNII: HG3GR8HU7X)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
ASCORBYL DIPALMITATE (UNII: 624RX3IESR)  
HOREHOUND (UNII: K08036XEJV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)  
PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POTATO PULP (UNII: 844I2DX0IS)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
WATER (UNII: 059QF0KO0R)  
CAMELLIA OIL (UNII: T1PE06G0VE)  
SHEA BUTTER (UNII: K49155WL9Y)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
KHAYA SENEGALENSIS BARK (UNII: 1S7EDA839L)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70186-700-011 in 1 CARTON05/19/2022
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/19/2022
Labeler - Charlotte Tilbury Beauty Ltd. (218353520)

Revised: 5/2022
Document Id: d34669b8-acbd-7c93-e053-2a95a90adbe4
Set id: d34669b8-acbc-7c93-e053-2a95a90adbe4
Version: 1
Effective Time: 20220511
 
Charlotte Tilbury Beauty Ltd.