FDA.reportPublic FDA data

Reboncel Ultra Sun Block Cream SPF 50

Manufacturer
ENBIOSCIENCE CO.,LTD
Effective date
2022-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:52:32

Label at a glance#

ProductReboncel Ultra Sun Block 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. children under 6 months of age: ask a doctor. Sun Protections Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly use a sunscreen with a BroadSpectrum SPF value of 15 or higher and other sun ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxdie 2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE 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

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

DOSAGE & ADMINISTRATION 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.
  • children under 6 months of age: ask a doctor.
  • Sun Protections Measures.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly use a sunscreen with a BroadSpectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

  • protect the product in this container from excessive heat and direct sun
  • refer to inset for complete labeling information

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, Butylene Glycol, Caprylic/Capric Triglyceride, Titanium Dioxide, Cetyl Ethylhexanoate, Betaine, Dimethicone, Niacinamide,Polysorbate 60, Sodium Hyaluronate, Isoamyl p-Methoxycinnamate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Butyrospermum Parkii (Shea) Butter, Silica, Cetyl PEG/PPG-10/1Dimethicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Bentonite, Sodium Chloride, Centella Asiatica Extract, Illicium Verum (Anise) Fruit Extract, Citrus Paradisi (Grapefruit)Fruit Extract, Nelumbium Speciosum Flower Extract, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Stearic Acid, Chlorphenesin, Tocopheryl Acetate, CeramideNP, Glycyrrhiza Glabra (Licorice) Root Extract, Portulaca Oleracea Extract, Althaea Rosea Flower Extract, Aloe Barbadensis Leaf Extract, Allantoin, Adenosine, Vitis Vinifera (Grape)Callus Culture Extract, Nelumbo Nucifera Callus Culture Extract, Panax Ginseng Callus Culture Extract, Camellia Sinensis Callus Culture Extract, Fragrance

Questions?

OTC - QUESTIONS SECTION

E-mail: info@reboncelco.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REBONCEL

SPF 50+, PA+++

ULTRA
SUN BLOCK CREAM

INTENSIVE UV CUT, WHITENING
AND WRINKLE CARE PROGRAM

BIOSCIENCE
ON YOUR SKIN

SKIN LIFE SCIENCE
OF ONE DROP

RE:BORN
RE:GAIN
RE:PAIR
RE:JUVENATE

> HIGH PERFORMANCE UV CUT
> ULTRA WHITENING FORMULA
> WRINKLE CARE FORMULA
> MOISTURIZING CARE

50 ml

Reboncel Ultra Sun Block SPF50 ICReboncel Ultra Sun Block SPF50 IC

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76192-20176192-201-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT

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
f06ed5d0-1abc-1bb9-e053-2995a90abd03ea255d3e-acb8-8595-e053-2995a90a53da2022-12-22WarningsExact identifier
spl set id: ea255d3e-acb8-8595-e053-2995a90a53da

Reported adverse events (FAERS/openFDA)#

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