FDA.reportPublic FDA data

21STAY A Thera Sun Block

Manufacturer
Oracle Cosmetic Co., Ltd. | COSON Co., Ltd._Osan Plant
Effective date
2017-11-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:59

Label at a glance#

Product21STAY A Thera Sun Block
Active ingredientOCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE, OCTISALATE, HOMOSALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.00%
Zinc Oxide 5.82%
Titanium Dioxide 5.46%
Octisalate 4.00%
Homosalate 2.00%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months


WARNINGS SECTION

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 using and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Glycerin, PEG-10 Dimethicone, Dicaprylyl Ether, Polymethyl Methacrylate, Dimethicone, Silica, Disteardimonium Hectorite, Sodium Chloride, Aluminum Hydroxide, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Bis-Ethylhexyloxyphenol, Polymethylsilsesquioxane, Stearic Acid, Fragrance, Phenoxyethanol, Dimethicone/Vinyl DimethiconeCrosspolymer, Sorbitan Sesquioleate, Dimethicone/Methicone Copolymer, Propanediol, Ethylhexylglycerin, Butylene Glycol, Octyldodecanol, Bambusa Vulgaris Extract, Echium Plantagineum Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cardiospermum HalicacabumFlower/Leaf/Vine Extract, Lepidium Meyenii Root Extract, Vitis Vinifera (Grape) Seed Oil, Tocopherol, Vegetable Oil, Camellia Sinensis Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Maltodextrin

OTHER SAFETY INFORMATION

Protect the product in the container from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71883-001-022023-05-26C16284748780-1d6a99b39-e9d4-a426-e053-dadaa90af4c2Drug Facts
71883-001-022022-01-28C16284748780-1d6a99b39-e9d4-a426-e053-dadaa90af4c2Drug Facts

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71883-00171883-001-01, 71883-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
Water059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
Dicaprylyl Ether77JZM5516ZIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CHIA SEEDNU0OLX06F8IACT
CENTELLA ASIATICA7M867G6T1UIACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
1,2-HexanediolTR046Y3K1GIACT
BEMOTRIZINOLPWZ1720CBHIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
Stearic Acid4ELV7Z65APIACT
PhenoxyethanolHIE492ZZ3TIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
Sorbitan Sesquioleate0W8RRI5W5AIACT
PROPANEDIOL5965N8W85TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
Butylene Glycol3XUS85K0RAIACT
Octyldodecanol461N1O614YIACT
BAMBUSA VULGARIS TOPFIW80T6P6VIACT
ECHIUM PLANTAGINEUM SEED OILPIB7XBU8XWIACT
SUNFLOWER OIL3W1JG795YIIACT
CARDIOSPERMUM HALICACABUM FLOWERING TOPMZP2508BRRIACT
LEPIDIUM MEYENII ROOTHP7119212TIACT
GRAPE SEED OIL930MLC8XGGIACT
TocopherolR0ZB2556P8IACT
CORN OIL8470G57WFMIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SAGE065C5D077JIACT

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
fc9dc102-6b53-8e5b-e053-6294a90ab3df98f5012c-3e56-43cf-ae6b-29399e5244b22023-05-26WarningsExact identifier
spl set id: 98f5012c-3e56-43cf-ae6b-29399e5244b2

Reported adverse events (FAERS/openFDA)#

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