CELLROMAX SUN BLOCK- octinoxate, titanium dioxide, zinc oxide, octisalate cream 
Pharmacist&Health Co., Ltd.

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.

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Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 6.24%, Zinc Oxide 4.455%, Ethylhexyl Salicylate3.0%

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: Sunscreen

Directions: 1. Apply after basic skin care product. 2. Spread an appropriate amount over the entire face following the skin texture. 3. Reapply as required.

Do not use on damaged or broken Skin. Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children.

For external use only.

Apply appropriate amount on your skin.

Apply with your skin before direct sunlight.

Cellromax Sunblock

CELLROMAX SUN BLOCK 
octinoxate, titanium dioxide, zinc oxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79895-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.455 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.24 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79895-104-021 in 1 BOX11/17/2020
1NDC:79895-104-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/17/2020
Labeler - Pharmacist&Health Co., Ltd. (690417665)
Registrant - Pharmacist&Health Co., Ltd. (690417665)
Establishment
NameAddressID/FEIBusiness Operations
SOLEO COSMETIC Co., Ltd.557829412manufacture(79895-104)

Revised: 11/2020
Document Id: b444d3cf-4d45-6d08-e053-2a95a90ac6a1
Set id: b444d3cf-4d44-6d08-e053-2a95a90ac6a1
Version: 1
Effective Time: 20201116
 
Pharmacist&Health Co., Ltd.