FRE GLOW ME LIGHTWEIGHT TINTED MOISTURIZER MEDIUM DEEP- zinc oxide cream

Fre Glow Me Lightweight Tinted Moisturizer Medium Deep by

Drug Labeling and Warnings

Fre Glow Me Lightweight Tinted Moisturizer Medium Deep by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 19.2%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer 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 swallowed, call a Poison Control Center or get medical help right away.

Directions

Shake well before use

• Apply liberally 15 minutes before sun exposure
• Reapply:
• After 80 minutes of swimming or sweating
• Immediately after towel drying
• 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 10a.m. to 2p.m. 
• Wear long-sleeve shirts, pants, hats, and sunglasses. 
• Children under 6 months: ask a doctor

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

INGREDIENTS AND APPEARANCE

FRE GLOW ME LIGHTWEIGHT TINTED MOISTURIZER MEDIUM DEEP 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1402-1	1 in 1 CARTON	02/15/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/15/2023

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharm Ltd.		514678390	manufacture(69435-1402)