FDA.reportPublic FDA data

Rejuve Sunscreen 100

Manufacturer
HUMEX,INC. | Kolmar Korea
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:04

Label at a glance#

ProductRejuve Sunscreen 100
Active ingredientZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, HOMOSALATE
Label structure7 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

▪ Appy liberally 15 minutes before sun exposure ▪ Reapply at least every 2 hours ▪ Use a water-resistant sunscreen if swimming or sweating ▪ Children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient Purpose

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn

Warnings

WARNINGS AND PRECAUTIONS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 (1-800-222-1222) right away.

Directions

INSTRUCTIONS FOR USE SECTION

▪ Appy liberally 15 minutes before sun exposure
▪ Reapply at least every 2 hours
▪ Use a water-resistant sunscreen if swimming or sweating
▪ Children under 6 months of age: ask a doctor

Other Information

OTHER SAFETY INFORMATION

▪ protect the product in this container from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cyclomethicone,Glycerin,Propanediol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite,Magnesium Sulfate,Dimethicone,Glycol Dimethacrylate,Methyl Methacrylate Crosspolymer,Vinyl Dimethicone/Methicone,Silsesquioxane Crosspolymer,Triethoxycaprylylsilane,Fragrance,
Dimethicone/Peg-10/15 Crosspolymer,
Dimethicone/Vinyl Dimethicone,Crosspolymer,
Glyceryl Caprylate,Ethylhexylglycerin,Dipropylene Glycol,Ceramide Np,Sucrose Stearate,Sodium Citrate,Tocopherol,Cholesterol,Stearic Acid,Cholesteryl Macadamiate,Palmitic Acid,Butylene Glycol,Saccharide Isomerate,
Dipeptide Diaminobutyroyl Benzylamide,
Diacetate,Palmitoyl Tripeptide-5,Oligopeptide-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

display paneldisplay panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76344-8005-22024-07-30C16284748780-11030e365-1923-111a-e063-dadaa90a10e2b8cd9668-2b42-3336-e053-2a95a90a92dd
76344-8005-22024-01-30C16284748780-11030e365-1923-111a-e063-dadaa90a10e2b8cd9668-2b42-3336-e053-2a95a90a92dd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76344-8005-1Rejuve Sunscreen 10050 mL in 1 TUBECREAM502
76344-8005-2Rejuve Sunscreen 1001 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76344-8005REJUVE SUNSCREEN 100 (INC OXIDE,OCTINOXATE,OCTISALATE,HOMOSALATE,TITANIUM DIOXIDE) CREAM [HUMEX,INC.]2Legacy NDC, 2 package rows20230111_b8cd9668-2b42-3336-e053-2a95a90a92dd.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76344-800576344-8005-1, 76344-8005-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
OLIGOPEPTIDE-10Q46328TRNKIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
SUCROSE STEARATE274KW0O50MIACT
SODIUM CITRATE1Q73Q2JULRIACT
TOCOPHEROLR0ZB2556P8IACT
STEARIC ACID4ELV7Z65APIACT
PALMITIC ACID2V16EO95H1IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCOL DIMETHACRYLATE7BK5G69305IACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
1,2-HEXANEDIOLTR046Y3K1GIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIPROPYLENE GLYCOLE107L85C40IACT
CERAMIDE NP4370DF050BIACT
PALMITOYL TRIPEPTIDE-52A3916MQHOIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
CHOLESTEROL97C5T2UQ7JIACT
CHOLESTERYL MACADAMIATEDFP79OD7KPIACT
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE38H206R00RIACT
CYCLOMETHICONENMQ347994ZIACT

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
f1ec9ba8-a023-63c2-e053-2a95a90a72c6b8cd9668-2b42-3336-e053-2a95a90a92dd2023-01-10WarningsExact identifier
spl id: f1ec9ba8-a023-63c2-e053-2a95a90a72c6
spl set id: b8cd9668-2b42-3336-e053-2a95a90a92dd

Reported adverse events (FAERS/openFDA)#

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