Sheer Cover Nourishing Moisturizer SPF 15

Sheer Cover Nourishing Moisturizer by

Drug Labeling and Warnings

Sheer Cover Nourishing Moisturizer by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SHEER COVER NOURISHING MOISTURIZER SPF 15- octinoxate, octisalate, and oxybenzone lotion 
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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Sheer Cover Nourishing Moisturizer SPF 15

Drug Facts

Active Ingredients

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

Purpose

Sunscreen

Directions

Use daily for best results. Smooth onto clean skin. Allow Nourishing Moisturizer to absorb completely before applying makeup. May be blended with your favorite Sheer Cover mineral foundation to create your own tinted moisturizer.

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 your health care practitioner.

Inactive Ingredients

Water (Aqua), Octyldodecyl Neopentanoate, Glycerin, Emulsifying Wax NF, Dimethicone , Glyceryl Stearate, PEG-100 Stearate, Carbomer, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

SHEER COVER®

Nourishing Moisturizer
SPF 15

Oil-Free
Fragrance-Free
Alcohol-Free

2 fl. oz. 60 mL

Principal Display Panel - 60 mL Bottle Label
SHEER COVER NOURISHING MOISTURIZER  SPF 15
octinoxate, octisalate, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-694
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-694-1030 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/200612/31/2019
2NDC: 11410-694-2060 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/200612/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/200612/31/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 7/2010
Document Id: 0b884ae9-c7a7-4a8a-897f-4ca99cae8d89
Set id: 9f7e3523-20ac-431d-8fa9-97f047972799
Version: 2
Effective Time: 20100707
 
THE PROACTIV COMPANY LLC