PHYSICAL FACIAL BLOCK  SPF 30- zinc oxide, titanium dioxide cream 
Vivier Pharma, 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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Physical Facial Block

WARNINGS For external use only

When using this product:Keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

10% Titanium Dioxide  
8% Zinc Oxide

Purpose

Sunscreen

Sunscreen

Uses

Helps prevent sunburn. ■ Provides broadspectrum
UVA/UVB protection. ■ Ideal for daily
use; can be applied under makeup. ■ Optimal
for post-care or on sensitive skin.

Directions

Apply daily to face, neck and chest. ■ Apply
liberally 15-30 minutes before sun exposure and
as needed. ■ Reapply after towel drying,
swimming or sweating. ■ For children under
six months of age, consult a physician.

Inactive Ingredients

Alumina, Ammonium Acryloyldimethyltaurate,
Bis-PEG/PPG-16/16 PEG/PPG16/16
Dimethicone, Butylparaben, Camellia Sinensis
(Green Tea) Extract, Caprylic/Capric Triglyceride,
Ceteareth 20, Cetearyl Alcohol, Cetyl Dimethicone,
Citrus Medica Limonum (Lemon
Bioflavanoids) Peel Extract, Cyclomethicone,
C12-15 Alkyl Benzoate, Dimethicone,
Dipropylene Glycol Dibenzoate, Eicosene
Copolymer, Ethylparaben, Glycerin, Glyceryl
Stearate, Isopropyl Titanium Triisostearate
/Triethoxycaprylyl Crosspolymer, Methylparaben,
Phenoxyethanol, Polyhydroxystearic Acid,
Polysorbate 20, PPG-15 Stearyl Ether Benzoate,
Propylparaben, Pyrus Malus (Apple) Fruit
Extract, Saccharum Officinarum (Sugar Cane)
Extract, Sodium Ascorbyl Phosphate, Tocopheryl
Acetate, Water/Eau, Xanthan Gum.

Principal Display Panel

Physical Facial Block SPF 30 US Carton 07-6046-04

Physical Facial Block SPF 30 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHYSICAL FACIAL BLOCK  SPF 30
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2330
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.8 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SUGARCANE (UNII: 81H2R5AOH3)  
APPLE (UNII: B423VGH5S9)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67226-2330-61 in 1 BOX
160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/28/2006
Labeler - Vivier Pharma, Inc. (250996550)
Establishment
NameAddressID/FEIBusiness Operations
Vivier Pharma, Inc.250996550manufacture(67226-2330)

Revised: 4/2014
Document Id: 57618b68-238d-4a53-b7eb-fb5843f1e510
Set id: 62e8274b-815a-41e1-a984-97ea73ffed07
Version: 1
Effective Time: 20140410
 
Vivier Pharma, Inc.