FRE PROTECT ME LIGHTWEIGHT DAILY MOISTURIZER SPF 50- 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.

----------

Drug Facts

Active Ingredients

Zinc Oxide 24%

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, Tocopherol, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Panthenol, Triethoxycaprylylsilane, Lauryl Glucoside, Polyglyceryl-6 Laurate, Propanediol, Xanthan Gum, Myristyl Glucoside,Caprylic/Capric Triglyceride, Isomalt, Glycerin, Caprylyl Glycol, Lauroyl Lysine, Sodium Phytate, Argania Spinosa Leaf Extract,Ethylhexylglycerin, Caprylhydroxamic Acid, Citrus AurantiumBergamia (Bergamot) Fruit Oil, Cymbopogon Flexuosus Oil,Lavandula Angustifolia (Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract, Lecithin.

Questions or Comments

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

Product label

image description

FRE PROTECT ME LIGHTWEIGHT DAILY MOISTURIZER SPF 50 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1404
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 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)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69435-1404-11 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(69435-1404)

Revised: 2/2023
Document Id: f44839d4-6662-7a91-e053-2995a90a22ee
Set id: 3989eebc-7262-4cda-84a1-ca30b638b772
Version: 1
Effective Time: 20230209
 
Peer Pharm Ltd.