ISA SUNGUARD SPF 30- zinc oxide, titanium dioxide cream

Isa SunGuard SPF 30 by

Drug Labeling and Warnings

Isa SunGuard SPF 30 by is a Otc medication manufactured, distributed, or labeled by Isagenix International, LLC, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                        Purpose
Zinc Oxide 6.0%.......................................Sunscreen
Titanium Dioxide 2.3%..............................Sunscreen

PURPOSE

Uses   Helps prevent sunburn   Higher SPF gives more sunburn protection

WARNINGS

Warnings  For External use only

DO NOT USE

Do not use on irritated or broken skin

STOP USE

Stop use and ask a physician if rash, irritation or sensitivity develops and lasts.

WHEN USING

When using this product do not ger into eyes. If contact occurs, rinse eyes thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions  -  Apply liberally before sun exposure to the sun.  -  Reapply after excessive perspiration or swimming.  -  Ask a doctor before use on children under 3 years of age.

PRECAUTIONS

Other information  Sun alert:  Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

INACTIVE INGREDIENT

Inactive Ingredients  Water (Aqua/Eau), Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Polysorbate 80, Caprylyl Methicone, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Diethylhexyl Carbonate, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Panthenol, Allantoin, Disodium EDTA, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Triethoxysilyllethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Glycerin, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Algae Extract, Alumina, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorophenesin

DESCRIPTION

Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays.  Manufactured for Isagenix International LLC,  Distributed by Isagenix International LLC AZ 85286 USA.  Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada  3900949.000-00  Item #40040

PRINCIPAL DISPLAY PANEL

Reveal a New You  REJUVITY   REJUVITY  ISAGENIX

PRINCIPAL DISPLAY PANEL

Isa SunGuard All-natural  SPF 30 Featuring Zinc Oxide and Titanium Dioxide  3.4 OZ (100 ml)

PRINCIPAL DISPLAY PANEL

REJUVITY  ISAGENIX  Isa SunGuard  All-natural  SPF 30 Featuring Zinc Oxide and Titanium Dioxide  3.4 OZ (100 ml)   Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays.   Manufactured for Isagenix International LLC,  Distributed by Isagenix International LLC AZ 85286 USA.  Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada  3901021.000-00

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISA SUNGUARD SPF 30 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76187-850
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHAMOMILE (UNII: FGL3685T2X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76187-850-03	1 in 1 PACKAGE	12/19/2017
1		100 mL in 1 TUBE; 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	05/26/2011

Labeler - Isagenix International, LLC (144798480)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76187-850)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76187-850)