FRE BRONZE ME SUN-KISSED MINERAL SUNSCREEN SPF 50- zinc oxide cream

FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 by

Drug Labeling and Warnings

FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 24%

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

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

Inactive Ingredients

Water, Coco-Caprylate/Caprate, Dicaprylyl Ether,
Glycerin, Propanediol, Polyglyceryl-6 Stearate,
Silica, Polyhydroxystearic Acid, Vitis Vinifera (Grape)
Seed Oil, Rosa Canina Fruit Extract, Niacinamide,
Butyrospermum Parkii (Shea) Butter, Simmondsia
Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane,
Cetyl Alcohol, Xanthan Gum, Caprylyl Glycol,
Glyceryl Stearate, Argania Spinosa Kernel (Argan)
Oil, Panthenol, Ascorbyl Tetraisopalmitate, Lecithin,
Sclerotium Gum, Pullulan, Polyglyceryl-6 Behenate,
Caprylhydroxamic Acid, Tocopherol, Pongamia
Pinnata Seed Extract, Pongamol, Argania Spinosa
Leaf Extract, Argania Spinosa Callus Culture Extract,
Isomalt, Cananga Odorata Flower (Ylang-Ylang) Oil,
Iron Oxides (CI 77492), Iron Oxides (CI 77491),
Mica, Iron Oxides (CI 77499).

Questions & Comments

Call toll free 1-888-589-6243

Product Labeling

INGREDIENTS AND APPEARANCE

FRE BRONZE ME SUN-KISSED MINERAL SUNSCREEN SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1413
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
CI 77492 (UNII: EX438O2MRT)
CI 77491 (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CI 77499 (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
SILICA (UNII: ETJ7Z6XBU4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
NIACINAMIDE (UNII: 25X51I8RD4)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PANTHENOL (UNII: WV9CM0O67Z)
ARGAN OIL (UNII: 4V59G5UW9X)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TOCOPHEROL (UNII: R0ZB2556P8)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
PONGAMOL (UNII: 8Y19QCY6I4)
ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)
ISOMALT (UNII: S870P55O2W)
YLANG-YLANG OIL (UNII: 8YOY78GNNX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1413-1	1 in 1 CARTON	01/14/2025
1		100 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	01/14/2025

Labeler - Peer Pharm Ltd. (514678390)