Zirh Defend Repairing SPF15 Moisturizer

Dosage form: lotion
Ingredients: Octisalate 39.2mg in 1mL, Avobenzone 19.6mg in 1mL, Octocrylene 12.25mg in 1mL, Ensulizole 9.8mg in 1mL
Labeler: Procter & Gamble Manufacturing Company
NDC Code: 37000-735

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.

ZIRH
DEFEND
3

IMMEDIATELY SHIELDS SKIN AGAINST HARMFUL UV RAYS AND HELPS GUARD THE SKIN'S SURFACE AGAINST THE DAMAGING EFFECTS OF FREE RADICALS.

WITH REGULAR USE, CONTINUES TO POWERFULLY HYDRATE THE SKIN TO IMPROVE THE LOOK OF UV DAMAGE SUCH AS DARK SPOTS, FINE LINES AND WRINKLES.

DIRECTIONS

APPLY EVENLY BEFORE SUN EXPOSURE AND AS NEEDED. CHILDREN UNDER 6 MONTHS OF AGE: CONSULT A DOCTOR.

ACTIVE INGREDIENTS

OCTISALATE/ETHYLHEXYL SALICYLATE 4 %, AVOBENZONE/BUTYL METHOXYDIBENZOYLMETHANE 2 %, OCTOCRYLENE 1.25 %, ENSULIZOLE/PHENYLBENZIMIDAZOLE SULFONIC ACID 1 %.

NON-MEDICINAL INGREDIENTS

WATER/AQUA, GLYCERIN, NIACINAMIDE, POLYETHYLENE, DIMETHICONE, ISOPROPYL ISOSTEARATE, TRIETHANOLAMINE, PENTYLENE GLYCOL, PANTHENOL, STEARYL ALCOHOL, BEHENYL ALCOHOL, CETYL ALCOHOL, DIMETHICONOL, SQUALANE, BUTYROSPERMUM PARKII (SHEA) BUTTER, CETEARYL ALCOHOL, PERSEA GRATISSIMA (AVOCADO) OIL, MYRISTYL ALCOHOL, TOCOPHERYL ACETATE, SILICA DIMETHICONE SILYLATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, HYDROXYETHYLCELLULOSE, CETEARYL GLUCOSIDE, PEG-100 STEARATE, CARBOMER, PEG-4 LAURATE, PEG-4 DILAURATE, PEG-4, BENZYL ALCOHOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, DISODIUM EDTA, IODOPROPYNYL BUTYLCARBAMATE

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 AND IRRITATION DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

PRINCIPAL DISPLAY PANEL - 100 mL Carton

ZIRH

DEFEND
3

REPAIRING SPF 15
MOISTURIZER

100 mL e 3.3 FL. OZ.

ZIRH DEFEND REPAIRING SPF15 MOISTURIZER 
octisalate, avobenzone, octocrylene, and ensulizole lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-735
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octisalate (Octisalate) Octisalate39.2 mg  in 1 mL
Avobenzone (Avobenzone) Avobenzone19.6 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene12.25 mg  in 1 mL
Ensulizole (Ensulizole) Ensulizole9.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
NIACINAMIDE 
DIMETHICONE 
TROLAMINE 
PENTYLENE GLYCOL 
PANTHENOL 
STEARYL ALCOHOL 
DOCOSANOL 
CETYL ALCOHOL 
SQUALANE 
SHEA BUTTER 
CETOSTEARYL ALCOHOL 
AVOCADO OIL 
MYRISTYL ALCOHOL 
CETEARYL GLUCOSIDE 
POLYOXYL 100 STEARATE 
PEG-4 DILAURATE 
POLYETHYLENE GLYCOL 200 
BENZYL ALCOHOL 
METHYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
EDETATE DISODIUM 
IODOPROPYNYL BUTYLCARBAMATE 
Packaging
#Item CodePackage Description
1NDC:37000-735-101 BOTTLE, PUMP (BOTTLE) in 1 CARTON
1100 mL in 1 BOTTLE, PUMP
2NDC:37000-735-077 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
Labeler - Procter & Gamble Manufacturing Company (004238200)
Establishment
NameAddressID/FEIOperations
Diversapack of California177711082MANUFACTURE

Revised: 01/2011
 
Procter & Gamble Manufacturing Company

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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