CELLROMAX SUN BLOCK- octinoxate, titanium dioxide, zinc oxide, octisalate cream

Cellromax Sun Block by

Drug Labeling and Warnings

Cellromax Sun Block by is a Otc medication manufactured, distributed, or labeled by Pharmacist&Health Co., Ltd., SOLEO COSMETIC Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

Purpose: Sunscreen

DESCRIPTION

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.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children.

WARNINGS

For external use only.

DOSAGE & ADMINISTRATION

Apply appropriate amount on your skin.

INDICATIONS & USAGE

Apply with your skin before direct sunlight.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CELLROMAX SUN BLOCK 
octinoxate, titanium dioxide, zinc oxide, octisalate cream

Product 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)