Lip Conditioner SPF 15

Product NDC
57627-107
11-digit product format
576270107
Labeler code
57627
Product ID
57627-107_5da96cd0-e136-c28f-e063-6394a90a9132
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE,OCTISALATE
Dosage form
JELLY
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-21
Substance
OCTINOXATE; OCTISALATE
Active strength
.278; .185 g/3.7g; g/3.7g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Lip Conditioner SPF 15
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE.278 g/3.7g
OCTISALATE.185 g/3.7g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-107-01Lip Conditioner SPF 15Merle Norman3.7 g in 1 TUBEJELLY3.719
57627-107-02Lip Conditioner SPF 15Merle Norman1 in 1 CARTONJELLY119

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
OCTISALATEACTIVE INGREDIENT4X49Y0596WLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
OCTINOXATEACTIVE MOIETY4Y5P7MUD51LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
OCTISALATEACTIVE MOIETY4X49Y0596WLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
ASTROCARYUM MURUMURU SEED BUTTERINACTIVE INGREDIENT12V64UPU6RLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
CERESININACTIVE INGREDIENTQ1LS2UJO3ALIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
ELAEIS GUINEENSIS FRUIT BUTTERINACTIVE INGREDIENTUYH3R74N56LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
HELIANTHUS ANNUUS SEED WAXINACTIVE INGREDIENT42DG15CHXVLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
MACADAMIA OILINACTIVE INGREDIENT515610SU8CLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-107LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]18Current NDC, Legacy NDC, 2 package rows20241004_b28459dc-c2df-4f8b-8b37-0090e223e6e9.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 65 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO BENEFIANCE NUTRIPERFECT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf644c67b-3a71-411b-b321-39a8b18af0c72026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation4b242b76-8aed-4939-9906-741828acd8152026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationefcf240f-95cb-45e0-b58a-9c8f3609aa552026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation270ecc83-4262-4102-a753-2acaf11360a02026-02-04WarningsExact identifier
application number: M020
Walgreens 50 Caramel and Pistachio Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4a038017-9f15-b4b2-e063-6294a90a1b232026-02-04WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationce6a28c1-56e6-4105-bc9d-9d1986ead4202026-02-04WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd52e2c61-edbc-4c26-b1a7-e8eb656db1882026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd365ed6d-a92f-473b-be19-b8b63d17f3b72026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETER0a3b4597-06fe-4689-9751-6577867d755e2026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERb83ea476-fa32-4405-9ae3-f294836edb622026-02-04WarningsExact identifier
application number: M020
Sunplus SPF50 Face Body SunscreenSUNSCREENI.Shay Cosmetics26d55baf-66dc-b1b8-e063-6394a90a670d2026-02-04WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel GlowZINC OXIDE SUNSCREENBentley Laboratories, LLC351217c4-8d71-41d9-ab08-c43857c0510c2026-02-04WarningsExact identifier
application number: M020
NIDA Invisible Fit Sun StickSUN STICKProso Corp49eca4f2-aae3-a0d5-e063-6394a90ab25f2026-02-03WarningsExact identifier
application number: M020
Shiny Hiny SPF 45 Mineral SunscreenZINC OXIDEShiny Hiny Products, LLC31adde36-5e1b-40ff-e063-6294a90a6f2e2026-02-03WarningsExact identifier
application number: M020
Walgreens 50 Passion Fruit Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49f030d8-959c-a3cd-e063-6294a90ae1ba2026-02-03WarningsExact identifier
application number: M020
Zealios Mineral SPF 30 SunscreenZINC OXIDEPersonal Best Products Inc. dba Zealiosc421b00c-6536-4455-81f6-01686f8c23882026-02-03WarningsExact identifier
application number: M020
Zealios Sport Performance Ultralight SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPersonal Best Products Inc. dba Zealios020bd1b4-da50-4117-a4f3-b74aa41873962026-02-03WarningsExact identifier
application number: M020
Adrien Arpel Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Incf65e1428-b79a-4126-862a-907ca17ee8f72026-02-02WarningsExact identifier
application number: M020
Flori Roberts Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Inc934d6b80-0cc3-4dcd-a25d-2191bd2736182026-02-02WarningsExact identifier
application number: M020
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREENHOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDEOracle Cosmetic Co., Ltd.21424f78-f8d5-6a9b-e063-6294a90ab7dc2026-02-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-107-01576270107013.7 g in 1 TUBE3.7 gHistorical
57627-107-02576270107021 TUBE in 1 CARTON (57627-107-02) / 3.7 g in 1 TUBE (57627-107-01) 1 tube2011-04-210000-00-00NoNoCurrent