FLORIDA BABE SPORT MINERAL SUNSCREEN STICK TINTED- titanium dioxide, zinc oxide stick

Florida Babe SPORT Mineral Sunscreen Stick Tinted by

Drug Labeling and Warnings

Florida Babe SPORT Mineral Sunscreen Stick Tinted by is a Otc medication manufactured, distributed, or labeled by Tichy Anesthesia PA, 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

FLORIDA BABE SPORT MINERAL SUNSCREEN STICK TINTED 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85337-220(NDC:58892-220)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	55 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINA (UNII: LMI26O6933)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
HEXYLDECANOL (UNII: 151Z7P1317)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CERESIN (UNII: Q1LS2UJO3A)
PEG-8 (UNII: B697894SGQ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CI 77491 (UNII: 1K09F3G675)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CITRIC ACID (UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85337-220-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	06/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/26/2023

Labeler - Tichy Anesthesia PA (041678845)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85337-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85337-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85337-220)