SPF 40 BROAD SPECTRUM NON-TINTED- zinc oxide cream

SPF 40 Broad Spectrum Non-Tinted by

Drug Labeling and Warnings

SPF 40 Broad Spectrum Non-Tinted by is a Otc medication manufactured, distributed, or labeled by Teton Dermatology Holdings, Inc., Custom Analytics LLC, Fragrance Manufacturing Inc., Fallien Cosmeceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

INDICATIONS & USAGE

WARNINGS

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

OTHER SAFETY INFORMATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 40 BROAD SPECTRUM NON-TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85339-205(NDC:58892-205)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85339-205-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/27/2023

Labeler - Teton Dermatology Holdings, Inc. (078310619)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85339-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85339-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85339-205)