LIGHT ILLUSION LUMINOUS MAKEUP NUDE-SKIN FEEL ALL-DAY WEAR BROAD SPECTRUM SPF18 SUNSCREEN 01- octinoxate, titanium dioxide, zinc oxide cream 
MAESA LLC

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.

----------

Bottle Back Label

Back Label-01

Bottle Front Label

Front Label-01

LIGHT ILLUSION LUMINOUS MAKEUP NUDE-SKIN FEEL ALL-DAY WEAR BROAD SPECTRUM SPF18 SUNSCREEN 01 
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71899-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE49 mg
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE99.79 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O) 1 mg
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.9 mg
FERRIC OXIDE RED (UNII: 1K09F3G675) 3.04 mg
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 40 mg
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) 30 mg
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) 10 mg
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 10 mg
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 8.8 mg
PHENOXYETHANOL (UNII: HIE492ZZ3T) 8.1 mg
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) 6 mg
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) 5 mg
YELLOW WAX (UNII: 2ZA36H0S2V) 3 mg
STEARALKONIUM HECTORITE (UNII: OLX698AH5P) 3 mg
FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 12.64 mg
FERROSOFERRIC OXIDE (UNII: XM0M87F357) 0.39 mg
MICA (UNII: V8A1AW0880) 17 mg
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.2 mg
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 2.89 mg
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) 2.25 mg
STEARIC ACID (UNII: 4ELV7Z65AP) 2 mg
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) 25 mg
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) 35 mg
GLYCERIN (UNII: PDC6A3C0OX) 30 mg
CETYL ETHYLHEXANOATE (UNII: 134647WMX4) 25 mg
PENTYLENE GLYCOL (UNII: 50C1307PZG) 20 mg
ETHYLHEXYL PALMITATE (UNII: 2865993309) 50 mg
WATER (UNII: 059QF0KO0R) 400 mg
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP) 10 mg
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 40 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71899-001-011 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/15/201812/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/15/201812/31/2022
Labeler - MAESA LLC (144282311)
Registrant - COSMAX USA, INC. (COSMAX USA, CORPORATION) (010990210)
Establishment
NameAddressID/FEIBusiness Operations
COSMAX USA, INC. (COSMAX USA, CORPORATION)010990210manufacture(71899-001)

Revised: 7/2023
 
MAESA LLC