Sheer Glow Even Tone Mineral Moisturizer SPF30 by USRX LLC / Bell International Laboratories

Drug Details [pdf]

SHEER GLOW EVEN TONE MINERAL MOISTURIZER SPF30- 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.

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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.

SheerGlow

SHEER GLOW EVEN TONE MINERAL MOISTURIZER SPF30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1908
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
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)
PROPANEDIOL (UNII: 5965N8W85T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70809-1908-1	66.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020

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

Labeler - USRX LLC (115270633)

Name	Address	ID/FEI	Business Operations
Establishment
Bell International Laboratories		967781555	manufacture(70809-1908)

Revised: 10/2021

Document Id: cea65a7f-e441-5b64-e053-2995a90a2043

Set id: a84a8f0f-75b5-70d4-e053-2995a90a9157

Version: 2

Effective Time: 20211018