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 10 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARKZINC OXIDEYounique, LLC2173666b-6c72-449d-9f40-098ea174f3e12026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEPZINC OXIDEYounique, LLC360ceb90-bec6-4fec-820a-a4d65008b8722026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEPZINC OXIDEYounique, LLC86c33a9e-9132-4377-8688-41e5844de62c2026-07-23WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTUREAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.edbfcf21-96c6-4519-8b08-f9b5ada7d1d72026-07-23WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO NUDE SKIN BASE SERUM TINT COBERTURA ANTIMANCHAS FPS 15 ANTI DARK SPOT COVERAGE SERUM TINT FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.574c96e9-77a2-778f-e063-6394a90a0aae2026-07-23WarningsExact identifier
application number: M020
SKINSUIT LIP SPF 30ZINC OXIDESkin Authority LLCcb24d714-f6cd-4518-b146-627cfe6c2ccd2026-07-23WarningsExact identifier
application number: M020
SKINSUIT FACE SPF 50ZINC OXIDESkin Authority LLC389fc528-fda5-485a-ab37-f99fcf3ed0b32026-07-23WarningsExact identifier
application number: M020
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
application number: M020
Native Daily Face Mineral Sunscreen Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3519e5bc-8c07-0617-e063-6394a90a65ae2026-07-22WarningsExact identifier
application number: M020
Tula Skincare Radiant Skin Brightening Serum Skin Tint Broad Spectrum SPF 30 01 Very Light NeutralAVOBENZONE, AND OCTISALATEThe Procter & Gamble Manufacturing Company366144c4-ec80-e435-e063-6394a90aba542026-07-22WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
application number: M020
YSE Beauty Instant Glow TrioAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLC6742e089-565a-40bc-8ffa-ec06e79860282026-07-21WarningsExact identifier
application number: M020
YSE Beauty The Roadies Packable AM RoutineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLCb0844331-d277-4cfb-957a-d8f9498836842026-07-21WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEBCM Cosmetique SAS328f96bc-fb68-33dc-e063-6294a90aecfa2026-07-21WarningsExact identifier
application number: M020
Sunscreen In the Raw SPF 50ZINC OXIDEBiomin LLC625523f0-366f-4148-b927-d726b7d1b9f42026-07-20WarningsExact identifier
application number: M020
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3a87ddee-241d-f972-e063-6294a90a7e892026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Daily Face Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a893b13-e7f5-c5b1-e063-6394a90a42532026-07-20WarningsExact identifier
application number: M020
Omnilux Mineral Facial SunscreenZINC OXIDEThe Lotus Global Group, Inc, dba GlobalMed Technologies5710c84b-9d6b-da4d-e063-6394a90a07372026-07-20WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact 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