Label: BRILLIE ULTIMATE SOOTHING SUN SHIELD- ethylhexyl methoxycinnamate, benzophenone-4, titanium dioxide cream
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- NDC Code(s): 80134-050-01, 80134-050-02
- Packager: Inhanzglobal 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 August 21, 2020
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INGREDIENTS AND APPEARANCE
BRILLIE ULTIMATE SOOTHING SUN SHIELD
ethylhexyl methoxycinnamate, benzophenone-4, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80134-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 g in 50 mL SULISOBENZONE (UNII: 1W6L629B4K) (SULISOBENZONE - UNII:1W6L629B4K) SULISOBENZONE 1.5 g in 50 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:80134-050-02 1 in 1 BOX 08/24/2020 1 NDC:80134-050-01 50 mL in 1 TUBE; 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 08/24/2020 Labeler - Inhanzglobal Co.,Ltd (695533746) Establishment Name Address ID/FEI Business Operations BRILLIANT 690381938 manufacture(80134-050)
