Isa SunGuard SPF 30

Dosage form: cream
Ingredients: ZINC OXIDE 6.0mL in 100mL, TITANIUM DIOXIDE 2.3mL in 100mL
Labeler: Isagenix International, LLC
NDC Code: 76187-850

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.

Isa SunGuard SPF 30

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

Uses   Helps prevent sunburn   Higher SPF gives more sunburn protection

Warnings  For External use only

Do not use on irritated or broken skin

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

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

Keep out of reach of children.

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

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.

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 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

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

Reveal a New You  REJUVITY   REJUVITY  ISAGENIX

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

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

ISA SUNGUARD SPF 30 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76187-850
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE6.0 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE2.3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ETHYLHEXYL PALMITATE 
CYCLOMETHICONE 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
ALKYL (C12-15) BENZOATE 
POLYSORBATE 80 
ISOHEXADECANE 
CETYL ALCOHOL 
PROPYLENE GLYCOL 
DIETHYLHEXYL CARBONATE 
TRIETHOXYCAPRYLYLSILANE 
ALOE VERA LEAF 
PANTHENOL 
ALLANTOIN 
EDETATE DISODIUM 
GLYCERIN 
BUTYLENE GLYCOL 
CHAMOMILE 
GREEN TEA LEAF 
GLYCYRRHIZA GLABRA 
ALUMINUM OXIDE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage Description
1NDC:76187-850-031 TUBE (TUBE) in 1 PACKAGE
1100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/26/2011
Labeler - Isagenix International, LLC (144798480)
Establishment
NameAddressID/FEIOperations
Englewood Lab, LLC172198223manufacture

Revised: 06/2011
 
Isagenix International, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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