MURUMURU BUTTER LIP CREAM SPF 15- avobenzone, octinoxate, octocrylene stick
Physicians Formula, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Murumuru Butter Lip Cream 10974-10985

PDP

MURUMURU BUTTER LIP CREAM SPF 15
avobenzone, octinoxate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:31645-203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.1 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.5 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISOSTEARYL HYDROXYSTEARATE (UNII: F7540880P0)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARMINIC ACID (UNII: CID8Z8N95N)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TRIMETHYLOLPROPANE TRIISOSTEARATE (UNII: Y32A6D7C6L)
CANDELILLA WAX (UNII: WL0328HX19)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIISOSTEARYL CITRATE (UNII: 50XT325OOH)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)
OCTYLDODECANOL (UNII: 461N1O614Y)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:31645-203-01	3.4 g in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2019	03/20/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2019	03/20/2022

Labeler - Physicians Formula, Inc. (021261805)

Revised: 8/2022

Document Id: e5d40762-3a54-0678-e053-2a95a90a3569

Set id: 83fffc1a-81d5-4226-e053-2a91aa0aff13

Version: 4

Effective Time: 20220809

Physicians Formula, Inc.