FDA.reportPublic FDA data

VITARAN REJUVENA SUNCARE

Manufacturer
BR PHARM CO. , Ltd.
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:49:52

Label at a glance#

ProductVITARAN REJUVENA SUNCARE
Active ingredientHOMOSALATE, ALLANTOIN, OCTISALATE, AVOBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Avobenzone 2.7%

Homosalate 13.5%

Octisalate 4.5%

OTC - PURPOSE SECTION

Skin Protectant

Sunscreen

INDICATIONS & USAGE SECTION

■ Helps prevent sunburn.

■ If used as directed with other sun protection measures (see Driections), decreases the risk of skin cancer and early skin aging caused by the sun

■ temporarily protects and helps relieve chapped or cracked skin

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

■ on damaged or broken skin.

OTC - WHEN USING SECTION

■ keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if ■ rash occurs.

■ condition worsens ■ symptoms last more than 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact poison control center right away

DOSAGE & ADMINISTRATION SECTION

■ apply liberally 15 minutes before sun exposure.

■ children under 6 months of age: Ask a doctor.

■ 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 including:
- limit time in the sun, especially from 10 a.m-2 p.m
- wear long-sleeved shirts, pants, hats, and sunglasses
■ reapply at least every 2 hours.
■ use a water-resistant sunscreen if swimming or sweating

OTHER SAFETY INFORMATION

■ Protect the product in the container from excessive heat and avoid storing it under direct sun.

INACTIVE INGREDIENT SECTION

Water
Betaine
Butylene Glycol
Cyclohexasiloxane
1,2-Hexanediol
Niacinamide
Polymethylsilsesquioxane
Glyceryl Stearate
PEG-100 Stearate
Cetearyl Alcohol
Palmitic Acid
Stearic Acid
Ammonium Acryloyldimethyltaurate/VP Copolymer
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Tromethamine
Ethylhexylglycerin
Sodium DNA
Adenosine
Disodium EDTA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VITARAN REJUVENA SUNCARE_boxVITARAN REJUVENA SUNCARE_boxVITARAN REJUVENA SUNCARE_tubeVITARAN REJUVENA SUNCARE_tube

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87435-1000-1VITARAN REJUVENA SUNCARE50 g in 1 BOTTLE, PLASTICCREAM501
87435-1000-2VITARAN REJUVENA SUNCARE1 in 1 BOXCREAM11

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87435-100087435-1000-1, 87435-1000-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
HOMOSALATEV06SV4M95SACTIB
ALLANTOIN344S277G0ZACTIB
BETAINE3SCV180C9WIACT
TROMETHAMINE023C2WHX2VIACT
WATER059QF0KO0RIACT
PALMITIC ACID2V16EO95H1IACT
STEARIC ACID4ELV7Z65APIACT
RAINBOW TROUT TESTIS DNA SODIUM4F8CQ9LQW9IACT
EDETATE DISODIUM7FLD91C86KIACT
OCTISALATE4X49Y0596WACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CETEARYL ALCOHOL2DMT128M1SIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%)YY2HMJ9NZFIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
AVOBENZONEG63QQF2NOXACTIB
ADENOSINEK72T3FS567IACT
NIACINAMIDE25X51I8RD4IACT

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
VITARAN REJUVENA SUNCAREALLANTOIN, AVOBENZONE, HOMOSALATE, OCTISALATEBR PHARM CO. , Ltd.4cb7af72-49f6-0738-e063-6394a90a79eb2026-03-12WarningsExact identifier
ndc (package): 87435-1000-2
ndc (package): 87435-1000-1
ndc (product): 87435-1000
ndc11 (package): 87435100002
ndc11 (package): 87435100001
spl id: 4cb7af72-49f7-0738-e063-6394a90a79eb
spl set id: 4cb7af72-49f6-0738-e063-6394a90a79eb

Reported adverse events (FAERS/openFDA)#

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