FRE GLOW ME SPF 50 LIGHTWEIGHT TINTED MOISTURIZER MEDIUM DEEP- zinc oxide cream

FRE GLOW ME SPF 50 Lightweight Tinted Moisturizer Medium Deep by

Drug Labeling and Warnings

FRE GLOW ME SPF 50 Lightweight Tinted Moisturizer Medium Deep by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd, Peer Pharm LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Zinc Oxide 24.0%

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, get medical help or contact a Poison Control Center right away.

Directions

Shake well before use.
Apply liberally 15 minutes before sun exposure.
Reapply:
After 40 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.
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses.
For children under 6 months of age: 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, 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, Caprylhydroxamic
Acid, Cymbopogon Flexuosus Oil, Lavandula Angustifolia
(Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract,
Lecithin, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron
Oxides (CI 77499).

Questions and Comments

Call toll free 1-888-589-6243

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRE GLOW ME SPF 50 LIGHTWEIGHT TINTED MOISTURIZER MEDIUM DEEP 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PANTHENOL (UNII: WV9CM0O67Z)
COCO-CAPRYLATE (UNII: 4828G836N6)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-6 LAURATE (UNII: Q48X4BL3TV)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCERIN (UNII: PDC6A3C0OX)
LAVENDER OIL (UNII: ZBP1YXW0H8)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHYTATE SODIUM (UNII: 88496G1ERL)
CARNOSINE (UNII: 8HO6PVN24W)
ARGANIA SPINOSA WHOLE (UNII: 83K6O4FR76)
WATER (UNII: 059QF0KO0R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOMALT (UNII: S870P55O2W)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1408-1	1 in 1 CARTON	07/15/2024
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/15/2024

Labeler - Peer Pharm Ltd (514678390)

Registrant - Peer Pharm Ltd (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharm LTD		514678390	manufacture(69435-1408)