Reboncel Ultra Sun Block Cream SPF 50

Reboncel Ultra Sun Block SPF 50 by

Drug Labeling and Warnings

Reboncel Ultra Sun Block SPF 50 by is a Otc medication manufactured, distributed, or labeled by ENBIOSCIENCE CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REBONCEL ULTRA SUN BLOCK SPF 50- zinc oxide cream 
ENBIOSCIENCE CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Reboncel Ultra Sun Block Cream SPF 50

Drug Facts

Active ingredient

Zinc oxdie 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, 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.
• 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

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

Inactive ingredients

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?

E-mail: info@reboncelco.com

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 SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76192-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76192-201-50	1 in 1 CARTON	10/01/2022	10/01/2022
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 final	M020	10/01/2022	10/01/2022

Labeler - ENBIOSCIENCE CO.,LTD (687650226)

Establishment
Name	Address	ID/FEI	Business Operations
ENBIOSCIENCE CO.,LTD		687650226	manufacture(76192-201)

Revised: 12/2022

Document Id: f06ed5d0-1abc-1bb9-e053-2995a90abd03

34390-5

Set id: ea255d3e-acb8-8595-e053-2995a90a53da

Version: 2

Effective Time: 20221222