FDA.reportPublic FDA data

Celesty

Manufacturer
MABA KOZMETIK LIMITED SIRKETI
Effective date
2020-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:40

Label at a glance#

ProductCelesty Sun Protection Series Solar Protection Fluid SPF 50
Active ingredientHOMOSALATE, AVOBENZONE, OCTOCRYLENE, OCTINOXATE
Label structure9 sections

Dosage and administration

• Apply minimum 30 minutes before sun exposure. • Repeat every 4 hours. • Reapply after swimming or sweating.

Storage and handling

Protect this product from excessive heat and direct sun. May stain some fabrics.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate: 6,4%

Avobenzone: 2,13%

Octocrylene: 5,58%

Octinoxate: 5,88%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin.

When using this product keep out eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply minimum 30 minutes before sun exposure. • Repeat every 4 hours. • Reapply after swimming or sweating.

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun. May stain some fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water\Aqua\Eau, Glycerin, Cetyl Alcohol, Peg-100 Stearate, Dimethicone, Phenoxyethanol, Glyceryl Stearate, Allantoin, Polymethylsilsesquioxane, Caprylyl Glycol, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Sodium Polyacrylate, Ethylhexylglycerin, Sodium PCA, Panthenol (Pro Vitamin B5), Tocopheryl Acetate (Vitamin E), Disodium EDTA, Sodium Hyaluronate.

SPL UNCLASSIFIED SECTION

shield with SUN PROTECTION series

VITAMIN E

PANTHENOL

HYALURONIC ACID

BEAUTY CARE

SOLAR PROTECTION FLUID SPF 50 (OILY SKIN)

Mineral Sun protection fluid for oily and combination skin types. Enriched with Panthenol and Vitamin E. Suitable for face and body.

Brace Beauty, Embrace Purity.

www.celesty.com

Made in TURKEY

MABA KOZMETIK A.S.

ESENTEPE MAH. YUZBASI KAYA ALDOGAN SOK.

ONUR IS MERKEZI NO:12 D:8 ISTANBUL

Distributed by CELESTY LLC

3970 NW 167TH ​ST. MIAMI GARDENS,

FL 33054 - USA

info@celesty.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81120-109-012022-07-29C16284748780-1e4f33bdf-a89c-d8a0-e053-dadaa90a6e4eCelesty SUN PROTECTION series SOLAR PROTECTION FLUID SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81120-109-01CelestySun Protection Series Solar Protection Fluid SPF 5075 mL in 1 TUBECREAM751
81120-109-01CelestySun Protection Series Solar Protection Fluid SPF 501 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81120-109CELESTY SUN PROTECTION SERIES SOLAR PROTECTION FLUID SPF 50 (HOMOSALATE, AVOBENZONE, OCTOCRYLENE, OCTINOXATE) CREAM [MABA KOZMETIK LIMITED SIRKETI]1Legacy NDC, 2 package rows20210109_7bd1a7ed-139d-4c30-9e86-010b7eb85c19.zip

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
81120-10981120-109-01

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
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALLANTOIN344S277G0ZIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYALURONATE SODIUMYSE9PPT4THIACT

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
d5d692e5-6286-4a01-963e-dd89097b773e7bd1a7ed-139d-4c30-9e86-010b7eb85c192020-12-08WarningsExact identifier
spl id: d5d692e5-6286-4a01-963e-dd89097b773e
spl set id: 7bd1a7ed-139d-4c30-9e86-010b7eb85c19

Reported adverse events (FAERS/openFDA)#

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