FDA.reportPublic FDA data

CoreTex Sun X SPF 30 Thin

Product NDC
65753-101
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

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 Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65753-101-10657530101107 mL in 1 POUCH7 mlHistorical
65753-101-116575301011159 mL in 1 BOTTLE, SPRAY (65753-101-11) 59 ml2019-11-220000-00-00NoNoCurrent
65753-101-1265753010112118 mL in 1 BOTTLE, SPRAY (65753-101-12) 118 ml2019-11-220000-00-00NoNoCurrent
65753-101-226575301012225 PACKET in 1 CONTAINER (65753-101-22) > 7 mL in 1 PACKET25 packet2019-11-220000-00-00NoNoCurrent
65753-101-236575301012350 PACKET in 1 CONTAINER (65753-101-23) > 7 mL in 1 PACKET50 packet2019-11-220000-00-00NoNoCurrent
65753-101-246575301012450 PACKET in 1 CARTON (65753-101-24) > 7 mL in 1 PACKET50 packet2019-11-220000-00-00NoNoCurrent
65753-101-2565753010125100 PACKET in 1 CARTON (65753-101-25) > 7 mL in 1 PACKET100 packet2019-11-220000-00-00NoNoCurrent
65753-101-2665753010126300 PACKET in 1 BOX (65753-101-26) > 7 mL in 1 PACKET300 packet2019-11-220000-00-00NoNoCurrent
65753-101-276575301012716 PACKET in 1 BOX (65753-101-27) > 7 mL in 1 PACKET16 packet2018-11-220000-00-00NoNoCurrent