SHEER GLOW- zinc oxide cream

Sheer Glow by

Drug Labeling and Warnings

Sheer Glow by is a Otc medication manufactured, distributed, or labeled by USRX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Zinc Oxide 11.6%

Purpose

Sunscreen

Use(s):

Helps prevent sunburn.

If used as directed with other sun protection measures (see directions), decreases the risk of skin canger and early skin aging caused by the sun.

Warnings:

For External use only.

Do not use

on damaged or broken skin.

When using this product,

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For Sunscreen use:

• Apply liberally and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10 a.m. to 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses
• Children under 6 months: ask a doctor

INACTIVE INGREDIENTS:

Water (Aqua), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Undecylcrylene Dimethicone, Cetearyl Olivate, Polyester-8, Polyglyceryl-3 Beeswax, Carthamus Tinctorius (Safflower) Oleosomes, Sorbitan Olivate, Propanediol, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Caprylyl Glycol, Hydrolyzed Wheat Protein/PVP Crosspolymer, Xanthan Gum, Bisabolol, Caprylhydroxamic Acid, Sodium Gluconate, Citrus Reticulata (Tangerine) Peel Oil, Carthamus Tinctorius (Safflower) Seedcake Extract, Citrus Grandis (Grapefruit) Fruit Extract.

Other Information:

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHEER GLOW 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1910
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	11.6 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PUMMELO (UNII: ET1TN5W71X)
MANDARIN OIL (UNII: NJO720F72R)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PROPANEDIOL (UNII: 5965N8W85T)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
CARTHAMUS TINCTORIUS SEEDCAKE (UNII: DHQ13F4N2W)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70809-1910-1	1 in 1 BOX	07/19/2001
1		66.5 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70809-1910-2	1 in 1 BOX	06/01/2021
2		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/19/2001

Labeler - USRX LLC (115270633)