FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50

Manufacturer
Peer Pharm Ltd.
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:03

Label at a glance#

ProductFRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

• 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 tim...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION SECTION

  • 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

WARNINGS SECTION


• 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

OTC - ASK DOCTOR SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

• 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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Call toll free 1-888-589-6243

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRE BRONZE ME SPF 50FRE BRONZE ME SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1413-1FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 501 in 1 CARTONCREAM12
69435-1413-1FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50100 mL in 1 BOTTLE, PUMPCREAM1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1413FRE BRONZE ME SUN-KISSED MINERAL SUNSCREEN SPF 50 (ZINC OXIDE) CREAM [PEER PHARM LTD.]2Current NDC, 2 package rows20250131_2cd958a3-bad6-725e-e063-6294a90a8578.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-141369435-1413-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50ZINC OXIDEPeer Pharm Ltd.2cd958a3-bad6-725e-e063-6294a90a85782025-01-30WarningsExact identifier
ndc (package): 69435-1413-1
ndc (product): 69435-1413
ndc11 (package): 69435141301
spl id: 2ce888d6-1bd1-fddd-e063-6294a90a809b
spl set id: 2cd958a3-bad6-725e-e063-6294a90a8578

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.