Super BB All-in-One Compact Cream by Physicians Formula Inc Super BB Compact Crm-PF

Super BB All-in-One Compact Cream by

Drug Labeling and Warnings

Super BB All-in-One Compact Cream by is a Otc medication manufactured, distributed, or labeled by Physicians Formula Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPER BB ALL-IN-ONE COMPACT CREAM SPF 30- titanium dioxide, zinc oxide paste 
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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Super BB Compact Crm-PF

Warning:  For external use only.  Do not use on damaged or broken skin

When using this product keep out of eyes.  Rinse with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients:  Titanium Dioxide 3.52%, Zinc Oxide 4.48%

Purpose:  Sunscreen

SUPER BB ALL-IN-ONE COMPACT CREAM  SPF 30
titanium dioxide, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.52 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.48 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CANDELILLA WAX (UNII: WL0328HX19)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM ALUMINOMETASILICATE TYPE I-A (UNII: 7LVU907546)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31645-170-02	1 in 1 BOX	12/01/2013	12/31/2019
1	NDC: 31645-170-01	8 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2013	12/31/2019

Labeler - Physicians Formula Inc (021261805)

Registrant - Physicians Formula Inc (021261805)

Revised: 12/2019

Document Id: 9a0471bd-543c-3519-e053-2995a90abf9f

34390-5

Set id: d2cc50ff-4155-4c17-935f-78e530b5ef4c

Version: 4

Effective Time: 20191218

 

Physicians Formula Inc