MedPath
FDA Product

Broad Spectrum SPF45

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Broad Spectrum SPF45

83286-008

Regulatory Information

83286-008

M020

C200263

May 1, 2025

USA

DRMTLGY Broad Spectrum SPF45

HUMAN OTC DRUG LABEL

2

Company Information

Drmtlgy, LLC

094762235

Active Ingredients

ZINC OXIDE

Quantity: 12 g in 100 g

Code: SOI2LOH54Z

Class Code: ACTIM

OCTINOXATE

Quantity: 7.5 g in 100 g

Code: 4Y5P7MUD51

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

OCTYLDODECYL NEOPENTANOATE

Code: X8725R883T

Class Code: IACT

CYCLOMETHICONE 5

Code: 0THT5PCI0R

Class Code: IACT

NIACINAMIDE

Code: 25X51I8RD4

Class Code: IACT

HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)

Code: 86FQE96TZ4

Class Code: IACT

POLYISOBUTYLENE (1000 MW)

Code: 5XB3A63Y52

Class Code: IACT

PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER

Code: MVJ3AD73GG

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

OLETH-3 PHOSPHATE

Code: 8Q0Z18J1VL

Class Code: IACT

.ALPHA.-TOCOPHEROL ACETATE

Code: 9E8X80D2L0

Class Code: IACT

POLYGONUM AVICULARE TOP

Code: ZCD6009IUF

Class Code: IACT

HYALURONATE SODIUM

Code: YSE9PPT4TH

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

PHENOXYETHANOL

Code: HIE492ZZ3T

Class Code: IACT

ETHYLHEXYLGLYCERIN

Code: 147D247K3P

Class Code: IACT

POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)

Code: RLA2U05Z4Q

Class Code: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE

Code: X75PL53TZJ

Class Code: IACT

TRIETHOXYCAPRYLYLSILANE

Code: LDC331P08E

Class Code: IACT

Active Moieties

ZINC CATION

Code: 13S1S8SF37

OCTINOXATE

Code: 4Y5P7MUD51

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