Sheer Glow by USRX LLC / Bell International Laboratories

Sheer Glow by

Drug Labeling and Warnings

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

Drug Details [pdf]

SHEER GLOW- zinc oxide cream 
USRX 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.

----------

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 rsah occurs.

Keep out of reach of children.

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

Directions:

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

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:

Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Paradisi (Grapefruit) Fruit Extract, Citrus Reticulata (Tangerine) Leaf Oil, Dimethicone, Ethyl Ferulate, Glycerin, Hydrolyzed Wheate Protein/PVP Crosspolymer, Methyl Dihydroabietate, Polyester-8, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Potassium Cetyl Phosphate, Propanediol, Sodium Chloride, Sodium Gluconate, Triethoxycaprylylsilane, Undercylcrylene Dimethicone, Water, Xanthan Gum

Other Information:

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

SHEER GLOW 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1907
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
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PROPANEDIOL (UNII: 5965N8W85T)
XANTHAN GUM (UNII: TTV12P4NEE)
ORANGE OIL (UNII: AKN3KSD11B)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
BENTONITE (UNII: A3N5ZCN45C)
LEVOMENOL (UNII: 24WE03BX2T)
ETHYL FERULATE (UNII: 5B8915UELW)
SODIUM GLUCONATE (UNII: R6Q3791S76)
UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GRAPEFRUIT (UNII: O82C39RR8C)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70809-1907-1	66.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/30/2020	04/30/2020

Labeler - USRX LLC (115270633)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture(70809-1907)

Revised: 6/2020

Document Id: a8ac9e09-7fdd-35a4-e053-2995a90ab5b4

34390-5

Set id: a4852411-c63f-749c-e053-2995a90a7dde

Version: 2

Effective Time: 20200622