Search by Drug Name or NDC

NDC 70186-0700-01 CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Primer .918; 2.038; 1.377; .612 g/30mL; g/30mL; g/30mL; g/30mL Details

CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Primer .918; 2.038; 1.377; .612 g/30mL; g/30mL; g/30mL; g/30mL

CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Primer is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Charlotte Tilbury Beauty Ltd.. The primary component is AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	70186-0700
Product ID	70186-700_d34669b8-acbd-7c93-e053-2a95a90adbe4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Primer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Octinoxate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.918; 2.038; 1.377; .612
Active Ingredient Units	g/30mL; g/30mL; g/30mL; g/30mL
Substance Name	AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Charlotte Tilbury Beauty Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70186-0700-01 (70186070001)

Pricing Information	N/A
NDC Package Code	70186-700-01
Billing NDC	70186070001
Package	1 TUBE in 1 CARTON (70186-700-01) / 30 mL in 1 TUBE
Marketing Start Date	2022-05-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d34669b8-acbc-7c93-e053-2a95a90adbe4 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/19/2022

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