SPF 40 BROAD SPECTRUM- titanium dioxide, zinc oxide cream

SPF 40 Broad Spectrum by

Drug Labeling and Warnings

SPF 40 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Teton Dermatology Holdings, Inc., Fragrance Manufacturing Inc., Custom Analytics LLC. 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 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85339-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	38 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77492 (UNII: EX438O2MRT)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALUMINA (UNII: LMI26O6933)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85339-203-50	53 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
Fragrance Manufacturing Inc.		793406000	manufacture(85339-203)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85339-203)