KIND RESTORE MOISTURIZING LIP BALM- titanium dioxide, zinc oxide stick

Kind Restore Moisturizing Lip Balm by

Drug Labeling and Warnings

Kind Restore Moisturizing Lip Balm by is a Otc medication manufactured, distributed, or labeled by POLISH BEAUTY, 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

KIND RESTORE MOISTURIZING LIP BALM 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85895-212(NDC:58892-212)
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
ALUMINA (UNII: LMI26O6933)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CERESIN (UNII: Q1LS2UJO3A)
CI 77499 (UNII: XM0M87F357)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CITRIC ACID (UNII: 2968PHW8QP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
PEG-8 (UNII: B697894SGQ)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYLDECANOL (UNII: 151Z7P1317)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
TOCOPHEROL (UNII: R0ZB2556P8)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85895-212-45	1 in 1 CARTON	03/29/2024
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	03/29/2024

Labeler - POLISH BEAUTY (049659504)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85895-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85895-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85895-212)