CHARLOTTE TILBURY BROAD SPECTRUM SPF 50 SUNSCREEN INVISIBLE UV FLAWLESS PORELESS PRIMER- avobenzone, octinoxate, octisalate and octocrylene cream

CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless Primer by

Drug Labeling and Warnings

CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless Primer by is a Otc medication manufactured, distributed, or labeled by Charlotte Tilbury Beauty Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients...............Purpose

Avobenzone 3.00%............Sunscreen

Octinoxate 6.79%...............Sunscreen

Octisalate 4.50%................Sunscreen

Octocrylene 2.00%.............Sunscreen

PURPOSE

Active ingredients...............Purpose

Avobenzone 3.00%............Sunscreen

Octinoxate 6.79%...............Sunscreen

Octisalate 4.50%................Sunscreen

Octocrylene 2.00%.............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

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

Directions

• 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 a.m.-2 p.m.
• 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHARLOTTE TILBURY BROAD SPECTRUM SPF 50 SUNSCREEN INVISIBLE UV FLAWLESS PORELESS PRIMER 
avobenzone, octinoxate, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70186-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.918 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.038 g  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.377 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.612 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
CITRIC ACID (UNII: 2968PHW8QP)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ASCORBYL DIPALMITATE (UNII: 624RX3IESR)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CI 77499 (UNII: XM0M87F357)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
AGAR (UNII: 89T13OHQ2B)
CI 77492 (UNII: EX438O2MRT)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
HOREHOUND (UNII: K08036XEJV)
CI 77891 (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
KHAYA SENEGALENSIS BARK (UNII: 1S7EDA839L)
CAMELLIA OLEIFERA SEED OIL (UNII: T1PE06G0VE)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
CI 77491 (UNII: 1K09F3G675)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BHT (UNII: 1P9D0Z171K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTATO PULP (UNII: 844I2DX0IS)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70186-701-01	1 in 1 CARTON	02/01/2025
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2025

Labeler - Charlotte Tilbury Beauty Ltd. (218353520)