Label: PERBELLE CC SPF43 UVA UVB BROAD SPECTRUM- titanium dioxide cream
- NDC Code(s): 81186-000-01
- Packager: Perbelle Cosmetics Global Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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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
- Questions?
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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:
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INGREDIENTS AND APPEARANCE
PERBELLE CC SPF43 UVA UVB BROAD SPECTRUM
titanium dioxide creamProduct 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)
