SHEER COVER NOURISHING MOISTURIZER SPF 15- octinoxate, octisalate, and oxybenzone lotion

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]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

SHEER COVER NOURISHING MOISTURIZER  SPF 15
octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
TROLAMINE (UNII: 9O3K93S3TK)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-024-10	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2016
2	NDC: 70605-024-20	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/31/2016

Labeler - Guthy-Renker LLC (948861877)