FLORIDA BABE ACTIVE TINTED 20PERCENT ZINC OXIDE MINERAL SUNSCREEN- zinc oxide cream

Florida Babe Active Tinted 20percent Zinc Oxide Mineral Sunscreen by

Drug Labeling and Warnings

Florida Babe Active Tinted 20percent Zinc Oxide Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Tichy Anesthesia PA, 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

FLORIDA BABE ACTIVE TINTED 20PERCENT ZINC OXIDE MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85337-204
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
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CI 77491 (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
CI 77499 (UNII: XM0M87F357)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CI 77492 (UNII: EX438O2MRT)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85337-204-60	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/03/2021

Labeler - Tichy Anesthesia PA (041678845)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85337-204)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85337-204)