PERBELLE CC SPF43 UVA UVB BROAD SPECTRUM- titanium dioxide cream

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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

TITANIUM DIOXIDE 12%

Purpose

Sunscreen

Uses

• Helps protect sunburns 
• 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 Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water reistant sunscreen if swimming or sweating.
• spending time in the sun increases your risk of skin cancer and early skin aging. To decrese this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other skin protection measures including: Sun Protection Measures
• Limit time in the sun, especially from 10 am - 2 pm.
• Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age Ask  doctor.

Other information

• Protect the product in this container from excessive heat or direct sun.

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:

INGREDIENTS AND APPEARANCE

PERBELLE CC SPF43 UVA UVB BROAD SPECTRUM 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81186-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	120 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81186-000-01	1 in 1 BOX	01/20/2021
1		30 g 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 Drug	M020	01/20/2021

Labeler - Perbelle Cosmetics Global Ltd. (522003003)