BRILLIE ULTIMATE SOOTHING SUN SHIELD- ethylhexyl methoxycinnamate, benzophenone-4, titanium dioxide cream 
Inhanzglobal 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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Brillié Ultimate Soothing Sun Shield

Ultimate Soothing Sun Shield

BRILLIE ULTIMATE SOOTHING SUN SHIELD 
ethylhexyl methoxycinnamate, benzophenone-4, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80134-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 g  in 50 mL
SULISOBENZONE (UNII: 1W6L629B4K) (SULISOBENZONE - UNII:1W6L629B4K) SULISOBENZONE1.5 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SHEA BUTTER (UNII: K49155WL9Y)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.5 g  in 50 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
TROLAMINE (UNII: 9O3K93S3TK)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
GLYCERETH-26 (UNII: NNE56F2N14)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
NYLON-12 (UNII: 446U8J075B)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATERMELON (UNII: 231473QB6R)  
CITRULLINE (UNII: 29VT07BGDA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80134-050-021 in 1 BOX08/24/2020
1NDC:80134-050-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/24/2020
Labeler - Inhanzglobal Co.,Ltd (695533746)
Establishment
NameAddressID/FEIBusiness Operations
BRILLIANT690381938manufacture(80134-050)

Revised: 8/2020
Document Id: ad620c86-60dc-4428-e053-2a95a90aeb26
Set id: ad620c86-60db-4428-e053-2a95a90aeb26
Version: 1
Effective Time: 20200821
 
Inhanzglobal Co.,Ltd