FDA.reportPublic FDA data

CALIFORNIA ALOE OIL FREE SUN BLOCK

Manufacturer
NATURE REPUBLIC CO., LTD. | Kolmar Korea Co.,LTD. Gwanjeong Factory
Effective date
2019-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:47:16

Label at a glance#

ProductCALIFORNIA ALOE OIL FREE SUN BLOCK
Active ingredientOCTINOXATE, OCTISALATE
Label structure8 sections

Indications and uses

How to Use: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays

Dosage and administration

How to Use: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 6.00%, ETHYLHEXYL SALICYLATE 3.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Ingredients:
WATER, BUTYLENE GLYCOL, CYCLOPENTASILOXANE, ALCOHOL, ISOAMYL P-METHOXYCINNAMATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, 1,2-HEXANEDIOL, DIPROPYLENE GLYCOL, PEG/PPG-30/10 DIMETHICONE, TRIETHANOLAMINE, WATER, BUTYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, CAPRYLYL GLYCOL, FRAGRANCE, SILICA, CARBOMER, CETETH-10, PHENOXYETHANOL, ALLANTOIN, BEHENYL ALCOHOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SEA WATER, BUTYLENE GLYCOL, WATER, PHENOXYETHANOL, MORINDA CITRIFOLIA EXTRACT, ETHYLHEXYLGLYCERIN, WATER, BUTYLENE GLYCOL, HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, PHENOXYETHANOL, TOCOPHERYL ACETATE, SODIUM HYALURONATE

PURPOSE

OTC - PURPOSE SECTION

Purpose: UV Protection

WARNINGS

WARNINGS SECTION

Cautions:
For external use only.
Discontinue use if signs of irritation or rashes appear.
Keep out of reach of children.
Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION


How to Use: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION


How to Use: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51346-24351346-243-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
e5c729b8-ac1b-426a-96ce-f8e1c7188b31b1d66534-8305-4bdf-828b-3cc7ade6bf6f2021-07-13WarningsExact identifier
spl set id: b1d66534-8305-4bdf-828b-3cc7ade6bf6f

Reported adverse events (FAERS/openFDA)#

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