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

PDP

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Version: 4

Effective Time: 20191218

Physicians Formula Inc