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

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

Drug Labeling and Warnings

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

Drug Details [pdf]

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

• 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

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

Charlotte Tilbury

BROAD SPECTRUM

SPF 50

SUNSCREEN

INVISIBLE UV

FLAWLESS

PRIMER

30 mL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70186-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.038 g  in 30 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.918 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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70186-700-01	1 in 1 CARTON	05/19/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/19/2022

Labeler - Charlotte Tilbury Beauty Ltd. (218353520)