Perbelle CC Cream SPF43 UVA/UVB Broad Spectrum 81186-001-01

Perbelle CC SPF43 UVA UVB Broad Spectrum by

Drug Labeling and Warnings

Perbelle CC SPF43 UVA UVB Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Perbelle Cosmetics Global Ltd., KONAD CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

----------

Perbelle CC Cream SPF43 UVA/UVB Broad Spectrum 81186-001-01

Drug Facts

Active ingredients

OCTINOXATE 7.5 %

TITANIUM DIOXIDE 12%

Purpose

Sunscreen

Uses


helps prevent sunburn
higher SPF gives more sunburn protection
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 skin or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor


rash or irritation develops and lasts.

Keep out of reach of children


If swallowed, get medical help or contact a Poison Control Center right away.

Directions


■ apply liberally 15 minutes before sun exposure.
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 sunprotection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
■ children under 6 months of age: Ask a doctor
■ reapply at least every 2 hours.
■ use a water-resistant sunscreen if swimming or sweating.

Other information

■ protect this product from exessive heat and direct sun

■ Sun alert: Limiting sun exposure, wearing protective clothing, and using
sunscreens may reduce the risks of skin aging, skin
cancer, and other harmful effects of the sun.

Questions?

Call 1-646-328-6562

Inactive Ingredient


Water, Cyclomethicone, Cyclopentasiloxane, Hexyl Laurate, Butylene Glycol,
Isodecyl Neopentanoate, Amorphophallus Konjac Root Extract, Methyl
Trimethicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Polymethyl
Met-hacrylate, C12-15 Alkyl Benzoate, Niacinamide, PEG-10 Dimethicone, 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, Narcissus
Pseudo-Narcissus(Daffodil) Flower 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, Triethoxycaprylylsilane, Sorbitan Sesquioleate, Trihydroxystearin,
Triethanolamine, Adenosine, Aluminum Hydroxide, Stearic Acid, Synthetic
Fluorphlogopite, Silica Dimethyl Silylate, Zein, Zea Mays(Corn) Starch,
Hydrogenated Lecithin, Caprylic/Capric Triglyceride, Disodium EDTA,
Phenoxyethanol, Fragrance, Iron Oxides(CI 77491, CI 77492, CI 77499)

Package Labeling:

PERBELLE CC CREAM

PERBELLE CC SPF43 UVA UVB BROAD SPECTRUM 
titanium dioxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81186-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.6 g  in 30 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) 2.25 g  in 30 g
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: 81186-001-011 in 1 BOX10/31/2023
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 DrugM02010/31/202311/01/2023
Labeler - Perbelle Cosmetics Global Ltd. (522003003)
Establishment
NameAddressID/FEIBusiness Operations
KONAD CO LTD688329887manufacture(81186-001)

Revised: 11/2023