SHEER MINERAL SUNSCREEN BAR- titanium dioxide, zinc oxide stick

Sheer Mineral Sunscreen Bar by

Drug Labeling and Warnings

Sheer Mineral Sunscreen Bar by is a Otc medication manufactured, distributed, or labeled by BB MEDICAL & DERMATOLOGY INC, 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

SHEER MINERAL SUNSCREEN BAR 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85343-220(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
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
HEXYLDECANOL (UNII: 151Z7P1317)
CI 77492 (UNII: EX438O2MRT)
CERESIN (UNII: Q1LS2UJO3A)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
CITRIC ACID (UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CI 77499 (UNII: XM0M87F357)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
PEG-8 (UNII: B697894SGQ)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
CI 77491 (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALUMINA (UNII: LMI26O6933)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85343-220-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	04/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/15/2024

Labeler - BB MEDICAL & DERMATOLOGY INC (040029570)

Establishment
Name	Address	ID/FEI	Business Operations
CUSTOM ANALYTICS LLC		144949372	analysis(85343-220)

Establishment
Name	Address	ID/FEI	Business Operations
FRAGRANCE MANUFACTURING INC.		793406000	manufacture(85343-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85343-220)