FDA.reportPublic FDA data

CoreTex Sun X SPF 30 Thin

Product NDC
65753-101
Requested package NDC
65753-101-12
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 56 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UNME SOULMA CENTELLA and BEEF TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ZINC OXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACIDShenzhen Jufeng Qiyuan Trading Co., Ltd.4c1a3345-58c1-93c8-e063-6394a90a865e2026-03-03WarningsExact identifier
application number: M020
Botnia Gentle Sun SPF 30ZINC OXIDEBotnia, Inc005d0245-fe53-47e5-888b-683f58cd6d262026-03-03WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.64534ec3-396c-4c11-9ec1-e2615f7e24b12026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.9b7249e4-4c1f-40e7-a657-d40c53d9317f2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenSUNSCREENOld East Main Co.1673b8b1-08ad-40a5-8180-93333a8edb672026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.32036e41-2414-4498-8e1c-61511abf7a322026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 100AVOBENZONE HOMOSALATE OCTISALATEOld East Main Co.42266fa5-5f30-2a9f-e063-6394a90a1dfe2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAmazon.com Services LLCd4b4ebac-c6c2-474b-afc6-b80b8431e90f2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Fruit Snack SPF 15 Broad Spectrum Lip BalmFRUIT SNACK SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc24c2a9fc-892b-c74d-e063-6394a90af62c2026-03-03WarningsExact identifier
application number: M020
Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4c231aa1-75eb-c171-e063-6294a90a8b8b2026-03-03WarningsExact identifier
application number: M020
SPF 30 Mineral SunscreenZINC OXIDESmalls Brand LLC DBA Roe Wellness4c25b4ec-b045-7066-e063-6294a90ab8012026-03-03WarningsExact identifier
application number: M020
Good Weather Skin Daily Lip Sun Gloss SPF 30 Iced CoffeeZINC OXIDEGood Weather Inc.4c261e88-7f37-2361-e063-6294a90aa6022026-03-03WarningsExact identifier
application number: M020
Good Weather Skin All Over Sun Milk Face and Body SPF 50ZINC OXIDEGood Weather Inc.4c278acc-7cd5-0d85-e063-6394a90a3a722026-03-03WarningsExact identifier
application number: M020
Lekura - ZincDaily Natural Face Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4c2bed23-f77b-2c97-e063-6394a90a4ca52026-03-03WarningsExact identifier
application number: M020
NEOGEN DERMALOGY DAY-LIGHT PROTECTION AIRY SUNSCREEN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEOUTIN FUTURES CO.,LTD.4ddce1f0-44a3-7e0c-e063-6294a90a3f7d2026-03-03WarningsExact identifier
application number: M020
Bephor Reviving Suncream SPF50ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, ZINC OXIDEGyeongbuk Institute of IT Convergence Industry Technology4c055b22-94e9-ff0d-e063-6394a90ab2ec2026-03-02WarningsExact identifier
application number: M020
Bath and Body Works SPF At The BeachAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c315bdb-dc33-1737-e063-6294a90a31a42026-03-02WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d02c8d-cdc8-b8d6-e063-6294a90ad9e42026-03-02WarningsExact identifier
application number: M020
SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTISALATEOld East Main Co.a460e512-f268-4941-beb6-29df10fdbb3a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Tanning Sunscreen SPF 15AVOBENZONE HOMOSALATE OCTISALATEOld East Main Co.42258ebe-e3cc-4d70-e063-6294a90a96512026-03-02Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65753-101-1265753010112118 mL in 1 BOTTLE, SPRAY (65753-101-12) 118 ml2019-11-220000-00-00NoNoCurrent