Ice Elements SPF 15 Moisturizer

Ice Elements by

Drug Labeling and Warnings

Ice Elements by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ICE ELEMENTS  SPF 15 MOISTURIZER- octinoxate, octisalate, and oxybenzone cream 
THE PROACTIV COMPANY LLC

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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Ice Elements SPF 15 Moisturizer

Drug Facts

Directions

Apply in the morning to cleansed face and neck. Lightly massage into skin using upward and outward strokes. Use after application of Ice Elements Anti-Aging Serum and Eye Results. Makeup can be applied afterwards as desired.

Warnings

For external use only.

Keep out of reach of children.

Avoid eye area. If contact occurs, flush gently and thoroughly with water.

Discontinue use if rash or irritation occur. If irritation persists, consult a health care practitioner.

ACTIVE INGREDIENTS

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

Other Ingredients

Water, Octyldodecyl Neopentanoate, Glycerin, Cetearyl Alcohol, Polysorbate 60, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Carbomer, Triethanolamine, Disodium EDTA, Benzoic Acid, Chlorphenesin, Methylparaben, Phenoxyethanol, Sodium Benzoate

PRINCIPAL DISPLAY PANEL - 30 ml Tube Label

ice
elements®

spf 15
moisturizer

30 ml / 1 fl. oz e

Principal Display Panel - 30 ml Tube Label
ICE ELEMENTS   SPF 15 MOISTURIZER
octinoxate, octisalate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-839
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-839-1130 mL in 1 TUBE; Type 0: Not a Combination Product02/24/201012/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/24/201012/31/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 7/2010
Document Id: eb5f1597-e25d-4c10-aec5-e80e9468a86e
Set id: c6a73a89-3a67-416e-ad0e-2a8cf20cb861
Version: 2
Effective Time: 20100715
 
THE PROACTIV COMPANY LLC