FRE GLOW ME LIGHTWEIGHT TINTED MOISTURIZER MEDIUM DEEP- zinc oxide cream 
Peer Pharm Ltd.

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 19.2%

Purpose

Sunscreen

Uses

Warnings

Keep out of reach of children.

If swallowed, call a Poison Control Center or get medical help right away.

Directions

• Shake well before use

Other information

Protect the product in this container from excessive heat and direct sun. Do not use if the seal is broken.

Inactive Ingredients

Water (Aqua), Coco-Caprylate, Glyceryl Oleate Citrate,Stearyl/Octyldodecyl Citrate Crosspolymer, Titanium Dioxide, Iron Oxide Yellow (CI 77492), Lauryl Glucoside, Xanthan Gum, Panthenol, Argania Spinosa Kernel Oil, Polyglyceryl-6 Laurate, Propanediol,Polyhydroxystearic Acid, Triethoxycaprylylsilane, Isomalt, Caprylic/Capric Triglyceride, Glycerin, Myristyl Glucoside, Caprylyl Glycol, Sodium Phytate, Lauroyl Lysine, Argania Spinosa Leaf Extract, Caprylhydroxamic Acid, Tocopherol, Citrus Aurantium Bergamia(Bergamot) Fruit Oil, Cymbopogon Flexuosus Oil, Lavandula Angustifolia(Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract,Lecithin, Iron Oxide Red (CI 77491), Iron Oxide Black (CI 77499).

Questions or Comments

Call 951-297-7976 or visit www.kcare.co.il

Product label

image description

FRE GLOW ME LIGHTWEIGHT TINTED MOISTURIZER MEDIUM DEEP 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)  
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PANTHENOL (UNII: WV9CM0O67Z)  
PROPANEDIOL (UNII: 5965N8W85T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ISOMALT (UNII: S870P55O2W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
LAUROYL LYSINE (UNII: 113171Q70B)  
ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CARNOSINE (UNII: 8HO6PVN24W)  
ARGAN OIL (UNII: 4V59G5UW9X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69435-1402-11 in 1 CARTON02/15/2023
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/15/2023
Labeler - Peer Pharm Ltd. (514678390)
Registrant - Peer Pharm Ltd. (514678390)
Establishment
NameAddressID/FEIBusiness Operations
Peer Pharm Ltd.514678390manufacture(69435-1402)

Revised: 2/2023
Document Id: f4482e8b-cdfb-a420-e053-2a95a90a8eab
Set id: 45ed56e1-46cb-46de-b11a-e814a7446e57
Version: 1
Effective Time: 20230209
 
Peer Pharm Ltd.