SHEER GLOW- zinc oxide cream 
USRX LLC

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70809-1910 Sheer Glow

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:

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:

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.

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SHEER GLOW 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70809-1910
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION11.6 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70809-1910-11 in 1 BOX07/19/2001
166.5 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:70809-1910-21 in 1 BOX06/01/2021
215 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/19/2001
Labeler - USRX LLC (115270633)

Revised: 10/2023
Document Id: 08158b7c-7bcd-b9d4-e063-6294a90ad86e
Set id: c77f6973-04a7-260d-e053-2a95a90ab48a
Version: 4
Effective Time: 20231019
 
USRX LLC