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 31 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunPlus Healthy Skin Sunny Living SPF 30 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC9b168046-3536-4ba9-9b5f-4f8c50b8b3542026-05-14WarningsExact identifier
application number: M020
SunPlus Healthy Skin Sunny Living SPF 50 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC0e60ecee-d9f4-47e0-92f7-ff319e4422dd2026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 15 SunscreenOCTOCRYLENE 7.50% AVOBENZONE 2.50% OCTISALATE 5.00%S&C Hampton Sun LLC3ce75e74-b5d3-4fbe-8d44-9b6f14f354df2026-05-14WarningsExact identifier
application number: M020
Target Up and Up SPF 30 Deep Repair Facial Moisturizer SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51c9bdee-dcff-2818-e063-6294a90abb472026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 50 Baby MineralZINC OXIDE 20%S&C Hampton Sun LLC42037d8c-4787-4e16-93fe-0d19b6b888fd2026-05-14WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIE29c9d1cb-e249-47fa-a46d-42190e59d3522026-05-14WarningsExact identifier
application number: M020
Hampton SPF 15 UV-Advanced SunscreenHOMOSALATE 7.50% OCTISALATE 5.00% AVOBENZONE 3.00%S&C Hampton Sun LLC1659a681-6cf8-45ba-b1f8-e330eee3b9d42026-05-14WarningsExact identifier
application number: M020
Easy Everything SunscreenZINC OXIDEVLT Ventures LLC51cd48cf-38ae-f347-e063-6294a90a8a902026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 4OCTOCRYLENE 4.00% AVOBENZONE 2.00%S&C Hampton Sun LLC68763abc-0d6b-441c-9a99-cf3dc86e6deb2026-05-14WarningsExact identifier
application number: M020
Easy Everything SunscreenZINC OXIDEVLT Ventures LLC51cdbac3-7f44-d72d-e063-6294a90a2f992026-05-14WarningsExact identifier
application number: M020
Round Lab x OUWR Birch Juice Moisturizing UVLOCK Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4feb1010-469f-7e6e-e063-6394a90a9a9e2026-05-14WarningsExact identifier
application number: M020
Round Lab Summer Travel KitAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4f8722e2-4636-e8ba-e063-6294a90a91e42026-05-14WarningsExact identifier
application number: M020
La Roche Posay Anthelios UV Air Serum Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incf3d841aa-b4fe-4a9d-8ad2-edd4445852d22026-05-14WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incb746c24d-f775-4433-8519-49c3ec48ea0c2026-05-14WarningsExact identifier
application number: M020
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Inc92a1d6ce-aff3-45fc-8d98-20c4375aded82026-05-14WarningsExact identifier
application number: M020
MELAO TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATA,ETHYLHEXYL SALICYATEGuangzhou Haishi Biological Technology Co., Ltd.519d9f52-b704-d6cd-e063-6294a90a6e422026-05-13WarningsExact identifier
application number: M020
Hampton Sun SPF30 MineralZINX OXIDES&C Hampton Sun LLC019b0c1a-f9f3-4756-8b24-35bf4dc4aa222026-05-13WarningsExact identifier
application number: M020
Standard Procedure SPF 50 Sunscreen Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories34f6150d-9627-94a5-e063-6394a90ad4482026-05-13WarningsExact identifier
application number: M020
CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdefa9588-95be-4f5c-86bb-53d6a1df7f5f2026-05-13WarningsExact identifier
application number: M020
MELAO TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATEGuangzhou Haishi Biological Technology Co., Ltd.22982b28-37df-ed81-e063-6394a90a77db2026-05-12WarningsExact 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