Label: CELLROMAX SUN BLOCK- octinoxate, titanium dioxide, zinc oxide, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 79895-104-01, 79895-104-02 - Packager: Pharmacist&Health Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 16, 2020
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Dipropylene Glycol, Cetyl Ethylhexanoate, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, 1,2-Hexanediol, Niacinamide, Methyl Methacrylate Crosspolymer, Dimethicone, Hydrogenated C6-14 Olefin Polymers, PEG-10 Dimethicone, Ozokerite, Sodium Chloride, Disteardimonium Hectorite, Barium Sulfate, Magnesium Stearate, Aluminum Hydroxide, Sorbitan Sesquioleate, Stearic Acid, Citric Acid, Dimethicone/PEG-10/15 Crosspolymer, Polysilicone-11, Polyhydroxystearic Acid, Lavandula Angustifolia (Lavender) Oil, Boswellia Carterii Oil, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Lecithin, Hydrogen Dimethicone, Adenosine, Polyglyceryl-3 Polyricinoleate, Silica, Disodium EDTA, Magnesium Myristate, Propylene Glycol, Tripropylene Glycol, Sodium Citrate, Allantoin, Portulaca Oleracea Extract, Tocopherol, Alanine, Arginine, Histidine, Tyrosine, Leucine, Methionine
- PURPOSE
- DESCRIPTION
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CELLROMAX SUN BLOCK
octinoxate, titanium dioxide, zinc oxide, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79895-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.455 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.24 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) FRANKINCENSE OIL (UNII: 67ZYA5T02K) ISOSTEARIC ACID (UNII: X33R8U0062) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) ADENOSINE (UNII: K72T3FS567) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIPROPYLENE GLYCOL (UNII: 3C8845E7C1) SODIUM CITRATE (UNII: 1Q73Q2JULR) ALLANTOIN (UNII: 344S277G0Z) TOCOPHEROL (UNII: R0ZB2556P8) ARGININE (UNII: 94ZLA3W45F) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) NIACINAMIDE (UNII: 25X51I8RD4) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987) CERESIN (UNII: Q1LS2UJO3A) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LAVENDER OIL (UNII: ZBP1YXW0H8) ETHYLHEXYL PALMITATE (UNII: 2865993309) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALANINE (UNII: OF5P57N2ZX) HISTIDINE (UNII: 4QD397987E) LEUCINE (UNII: GMW67QNF9C) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM MYRISTATE (UNII: Z1917F0578) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) METHIONINE (UNII: AE28F7PNPL) PORTULACA OLERACEA LEAF (UNII: 9JW9D9JGHZ) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) TYROSINE (UNII: 42HK56048U) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79895-104-02 1 in 1 BOX 11/17/2020 1 NDC:79895-104-01 50 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/17/2020 Labeler - Pharmacist&Health Co., Ltd. (690417665) Registrant - Pharmacist&Health Co., Ltd. (690417665) Establishment Name Address ID/FEI Business Operations SOLEO COSMETIC Co., Ltd. 557829412 manufacture(79895-104)
