PHYSICAL FACIAL BLOCK SPF 30- zinc oxide, titanium dioxide cream

Physical Facial Block by

Drug Labeling and Warnings

Physical Facial Block by is a Otc medication manufactured, distributed, or labeled by Vivier Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PHYSICAL FACIAL BLOCK  SPF 30
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67226-2330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.8 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-2330-6	1 in 1 BOX
1		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/28/2006

Labeler - Vivier Pharma, Inc. (250996550)

Establishment
Name	Address	ID/FEI	Business Operations
Vivier Pharma, Inc.		250996550	manufacture(67226-2330)