VITARAN REJUVENA SUNCARE- allantoin, avobenzone, homosalate, octisalate cream

VITARAN REJUVENA SUNCARE by

Drug Labeling and Warnings

VITARAN REJUVENA SUNCARE by is a Otc medication manufactured, distributed, or labeled by BR PHARM CO. , Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Allantoin 0.5%

Avobenzone 2.7%

Homosalate 13.5%

Octisalate 4.5%

PURPOSE

Skin Protectant

Sunscreen

INDICATIONS & USAGE

■ 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

For external use only

■ on damaged or broken skin.

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

Stop use and ask a doctor if ■ rash occurs.

■ condition worsens ■ symptoms last more than 7 days

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

DOSAGE & ADMINISTRATION

■ 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITARAN REJUVENA SUNCARE 
allantoin, avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87435-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13.5 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BETAINE (UNII: 3SCV180C9W)
TROMETHAMINE (UNII: 023C2WHX2V)
WATER (UNII: 059QF0KO0R)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
RAINBOW TROUT TESTIS DNA SODIUM (UNII: 4F8CQ9LQW9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%) (UNII: YY2HMJ9NZF)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
NIACINAMIDE (UNII: 25X51I8RD4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87435-1000-2	1 in 1 BOX	03/11/2026
1	NDC: 87435-1000-1	50 g in 1 BOTTLE, PLASTIC; 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	03/11/2026

Labeler - BR PHARM CO. , Ltd. (557782379)

Registrant - BR PHARM CO. , Ltd. (557782379)

Establishment
Name	Address	ID/FEI	Business Operations
BR PHARM CO. , Ltd.		557782379	manufacture(87435-1000)