REALLY GREAT LIP SHIELD- titanium dioxide, zinc oxide stick

Really Great Lip Shield by

Drug Labeling and Warnings

Really Great Lip Shield by is a Otc medication manufactured, distributed, or labeled by JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION, 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

REALLY GREAT LIP SHIELD 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85585-212
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
STEARIC ACID (UNII: 4ELV7Z65AP)
CITRIC ACID (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
CI 77492 (UNII: EX438O2MRT)
CERESIN (UNII: Q1LS2UJO3A)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG-8 (UNII: B697894SGQ)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ALUMINA (UNII: LMI26O6933)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HEXYLDECANOL (UNII: 151Z7P1317)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Product Characteristics
Color		Score
Shape		Size
Flavor	LIME, KIWI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85585-212-45	1 in 1 CARTON	05/26/2022
1		4.5 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/26/2022

Labeler - JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION (557562910)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85585-212)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85585-212)