FDA.reportPublic FDA data

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 36 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
White Mint SPF 15 Broad Spectrum Lip BalmWHITE MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc50ff8c38-94f1-f589-e063-6294a90a5ba82026-05-04WarningsExact identifier
application number: M020
Surface Sun SPF 50 MineralZINC OXIDESurface Products Corpcabaf7e1-b940-4d6e-b21b-d99c3a4047a72026-05-04WarningsExact identifier
application number: M020
SPF 50 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corp503d6b48-3516-4264-9fe8-71a9939669fe2026-05-04WarningsExact identifier
application number: M020
Surface SPF 50 3oz Tinted mineral sunscreen with Water ResistanceZINC OXIDESurface Products Corp02b770cf-7351-444b-b2c8-ad112e9bea3e2026-05-04WarningsExact identifier
application number: M020
SPF 30 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corpd13c9e6e-a5da-4691-8792-9d6025e166d72026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
application number: M020
OBGE PORE-ZERO Oil CONTROL SUN StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAdapt Inc.67209e46-1b7a-42df-b31f-fcb3cefbd7e12026-05-03WarningsExact identifier
application number: M020
EquateOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWALMART INC2617e5bc-27a2-f187-e063-6394a90a69802026-05-03WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Rice Tinted Mineral Sun CreamZINC OXIDETHANK YOU FARMER CO., LTD20a44597-3d44-f0ea-e063-6294a90a903d2026-05-03WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.4df3e90e-98a0-edbf-e063-6394a90ae3c92026-05-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENEGrace and Fire USA Inc.4df6d28b-64ce-59b3-e063-6394a90a63602026-05-01WarningsExact identifier
application number: M020
EXTREME PROTECT SPF 30OCTINOXATE, ZINC OXIDESCIENCE OF SKINCARE LLCecc4d304-e7e2-45b6-b9b2-2c64d36308602026-05-01WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
application number: M020
Sun Shield Mineral UV Barrier Protect Broad Spectrum SPF 40 SunscreenZINC OXIDEObagi Cosmeceuticals LLC54a3f855-48de-4ae0-b1f0-e957398530652026-05-01WarningsExact identifier
application number: M020
MEDICUBE PDRN HYDRATING UV SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLEAPR US INC50a73981-985a-0a70-e063-6394a90a89cf2026-04-30WarningsExact identifier
application number: M020
Sky and Sol Body SunscreenNON- NANO ZINC OXIDEDelta Ecommerce LLC2ddaa628-0e81-c8a7-e063-6394a90a84f42026-04-30WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
application number: M020
Carmex 10 count variety pack Lip BalmOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.9c5168d5-31ed-4ce1-b16a-5f51f7e44ed22026-04-30WarningsExact 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