FDA.reportPublic FDA data

CoreTex Sun X SPF 30 Thin

Product NDC
65753-101
Requested package NDC
65753-101-11
11-digit product format
657530101
Labeler code
65753
Product ID
65753-101_0847f22b-ece4-e4c1-e063-6394a90a4d62
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone
Dosage form
LIQUID
Route
TOPICAL
Labeler
CoreTex Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-22
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
1; 5; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
CoreTex Sun X SPF 30 Thin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1 g/100mL
HOMOSALATE5 g/100mL
OCTINOXATE7.5 g/100mL
OCTISALATE5 g/100mL
OXYBENZONE6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
980388b5-8314-3143-e053-2995a90a7288Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-101-11CoreTex Sun X SPF 30 Thin59 mL in 1 BOTTLE, SPRAYLIQUID596
65753-101-12CoreTex Sun X SPF 30 Thin118 mL in 1 BOTTLE, SPRAYLIQUID1186
65753-101-22CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-22CoreTex Sun X SPF 30 Thin25 in 1 CONTAINERLIQUID256
65753-101-23CoreTex Sun X SPF 30 Thin50 in 1 CONTAINERLIQUID506
65753-101-23CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-24CoreTex Sun X SPF 30 Thin50 in 1 CARTONLIQUID506
65753-101-24CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-25CoreTex Sun X SPF 30 Thin100 in 1 CARTONLIQUID1006
65753-101-25CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-26CoreTex Sun X SPF 30 Thin300 in 1 BOXLIQUID3006
65753-101-26CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-27CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-27CoreTex Sun X SPF 30 Thin16 in 1 BOXLIQUID166
65753-101-10SunX SPF 30/BugX Wallmount7 mL in 1 POUCHLIQUID350 mL7.5 g in 100mL1
65753-101-10SunX SPF 30/BugX Wallmount7 mL in 1 POUCHLIQUID350 mL7.5 g in 100mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-101CORETEX SUN X SPF 30 THIN (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LIQUID [CORETEX PRODUCTS INC]6Current NDC, Legacy NDC, 14 package rows20231022_980388b5-8314-3143-e053-2995a90a7288.zip
65753-101SUNX SPF 30/BUGX WALLMOUNT KIT [CORETEX PRODUCTS INC]1Current NDC, Legacy NDC20231022_0846946b-a05d-826c-e063-6294a90a0a0f.zip
65753-101SUNX SPF 30/BUGX WALLMOUNT KIT [CORETEX PRODUCTS INC]1Current NDC, Legacy NDC20231022_08480b2a-a888-fb00-e063-6294a90a41ea.zip

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 5 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
application number: M020
Sunski Base Camp Face and Body Sunscreen SPF 45HOMOSALATE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLC2fc45f85-a6f8-4893-8b34-4db5e39cb6152026-08-20WarningsExact identifier
application number: M020
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Concierge Choice LLC5980055b-493e-4763-e063-6294a90a570f2026-08-20WarningsExact identifier
application number: M020
Lip Balm SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENESkin Script, LLC20c5fde7-ee8f-4b74-e063-6394a90a93ec2026-08-19WarningsExact identifier
application number: M020
Aloe UP .5OZ SPF 50 MINERAL SunscreenZINC OXIDE 14.69%Aloe Care International, LLC6ad80af3-78cd-4211-a5f2-68531aae264a2026-08-19WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsExact identifier
application number: M020
Mineral sunscreenMINERAL SUNSCREENGuangzhou Origin Beauty Cosmetics Co., Ltd.59713657-a7ef-1aee-e063-6394a90a326e2026-08-19WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 14.69%The Naked Beef820a9be-c94d-4fd5-b202-2dda5746a82a2026-08-18WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 20%The Naked Bee7dd2b1cd-e229-4eeb-8122-46fde5af10912026-08-18WarningsExact identifier
application number: M020
Sun Zapper - Baby pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee52faa-64a8-4bdf-e063-6294a90a65cf2026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Face pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee4feb3-6966-67f9-e063-6394a90a16d52026-08-17WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
application number: M020
Soleil Defense SunscreenBROAD SPECTRUM SPF 30AMARA MED SPA LLC594244b1-db3b-002b-e063-6394a90a03292026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
application number: M020
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Charleston Dermatology, P.C.59440f7f-4213-6e2b-e063-6394a90af4832026-08-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65753-101-116575301011159 mL in 1 BOTTLE, SPRAY (65753-101-11) 59 ml2019-11-220000-00-00NoNoCurrent