MINERAL TINTED SPF40 WITH CERAMIDES- zinc oxide cream

Mineral Tinted SPF40 with ceramides by

Drug Labeling and Warnings

Mineral Tinted SPF40 with ceramides by is a Otc medication manufactured, distributed, or labeled by Spalina LLC., 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

MINERAL TINTED SPF40 WITH CERAMIDES 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85360-208(NDC:58892-208)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CI 77499 (UNII: XM0M87F357)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CERAMIDE 3 (UNII: 4370DF050B)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85360-208-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/04/2020

Labeler - Spalina LLC. (105212651)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85360-208)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85360-208)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85360-208)