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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
Available from:
Physicians Formula, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
31645-203-01

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 SPF15

PDP

MURUMURU BUTTER LIP CREAM SPF 15

avobenzone, octinoxate, octocrylene stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:316 45-20 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

2.1 mg in 1 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

4.5 mg in 1 g

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

3.6 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ASTRO CARYUM ACULEATUM SEED O IL (UNII: JUP28 JPX3K)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

SHEA BUTTER (UNII: K49 155WL9 Y)

JO JO BA O IL (UNII: 724GKU717M)

LO W DENSITY PO LYETHYLENE (UNII: J245LN42AI)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

ASTRO CARYUM MURUMURU SEED BUTTER (UNII: 12V6 4UPU6 R)

STEVIA REBAUDIUNA LEAF (UNII: 6 TC6 NN0 8 76 )

FD&C BLUE NO . 1--ALUMINUM LAKE (UNII: J9 EQA3S2JM)

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

TRIDECYL TRIMELLITATE (UNII: FY36 J270 ES)

ISO STEARYL HYDRO XYSTEARATE (UNII: F7540 8 8 0 P0 )

MICA (UNII: V8 A1AW0 8 8 0 )

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

CARMINIC ACID (UNII: CID8 Z8 N9 5N)

MANGANESE VIO LET (UNII: 72M48 QQV8 Q)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

TRIMETHYLO LPRO PANE TRIISO STEARATE (UNII: Y32A6 D7C6 L)

CANDELILLA WAX (UNII: WL0 328 HX19 )

THEO BRO MA GRANDIFLO RUM SEED BUTTER (UNII: I711F13FXM)

.ALPHA.-TO CO PHERO L ACETATE, D- (UNII: A7E6 112E4N)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

PO LYBUTENE ( 14 0 0 MW) (UNII: 1NA5AO9 GH7)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

TRIISO STEARYL CITRATE (UNII: 50 XT325OOH)

TETRAHEXYLDECYL ASCO RBATE (UNII: 9 LBV3F0 7AZ)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

D&C RED NO . 7 (UNII: ECW0 LZ41X8 )

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:316 45-20 3-0 1 3.4 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 1/0 1/20 19

Physicians Formula, Inc.

Labeler -

Physicians Formula, Inc. (021261805)

Revised: 3/2019

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