PERBELLE CC SPF43 UVA UVB BROAD SPECTRUM- titanium dioxide cream 
Perbelle Cosmetics Global Ltd.

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Perbelle CC Cream SPF43 UVA/UVB Broad Spectrum

Drug Facts

Active ingredients

TITANIUM DIOXIDE 12%

Purpose

Sunscreen

Uses

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 Poison Control Center right away.

Directions

Other information

Questions?

Call 646.328.6562

Inactive Ingredient

Water, Ethylhexyl methoxycinnamte, Cyclomethicone, Cyclopentasiloxane, Hexyl Laurate, Butylene Glycol, Isodecyl neopentanoate, Amorphophallus Konjac Root Extract, Methyl Trimethicone, Bis-Ethylhexlyoxyphenol Methoxypehnyl Triazine, Polymethyl Met-hacrylate, C12-15 Alkyl Benzoate, Niacinamide, PEG-10 Dimethicone, Talc, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/leaf Extract, Rose Extract, Lilium Candidum Bulb Extract, Freesia Refracta Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/leaf Extract, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Hyaluronic Acid, Sorbitan Isostearate, Dimethicone, Polysilicone-11, Ozokerite, Calcium Stearate, Lauryl PEG/PPG-18/18 Methicone, Glycerin, Triethoxycaprylylylsilane, Sorbitan Sesquioleate, Trihydroxysteain, Triethanolamine, Adenosine, Aluminum Hydroxide, Stearic Acid, Synthetic Fluorphlogopite, Silica Dimethyl Silylate, Zein, Zea Mays (Corn) Strach, Hydrogented Lecithin, Caprylic/capric Triglyceride, Disodium EDTA, CI 77491, CI 77492, CI 77499, Propylparaben, Methylparaben, Phenoxyethanol, Fragrance

Package Labeling:

LabelLabel2

PERBELLE CC SPF43 UVA UVB BROAD SPECTRUM 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81186-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE120 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC)  
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
HYALURONIC ACID (UNII: S270N0TRQY)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CALCIUM STEARATE (UNII: 776XM7047L)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
TROLAMINE (UNII: 9O3K93S3TK)  
ADENOSINE (UNII: K72T3FS567)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
ZEIN (UNII: 80N308T1NN)  
STARCH, CORN (UNII: O8232NY3SJ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81186-000-011 in 1 BOX01/20/2021
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/20/2021
Labeler - Perbelle Cosmetics Global Ltd. (522003003)

Revised: 12/2023
Document Id: 0b6e43ea-38e7-10b0-e063-6394a90a5220
Set id: b5e2724e-9806-5bcc-e053-2a95a90a0508
Version: 3
Effective Time: 20231201
 
Perbelle Cosmetics Global Ltd.