FDA.reportPublic FDA data

CERAMIDE MAKEUP SPF 15

Product NDC
10967-668
11-digit product format
109670668
Labeler code
10967
Product ID
10967-668_0ec8e4c0-b69c-cd68-e063-6294a90a6034
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
REVLON
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-11
Substance
TITANIUM DIOXIDE; OCTINOXATE
Active strength
3; 4 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
CERAMIDE MAKEUP SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE3 mg/g
OCTINOXATE4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3ad9686-47ed-4b60-e053-2995a90abcddAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-668-01CERAMIDE MAKEUP SPF 1532 g in 1 JARCREAM324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-668CERAMIDE MAKEUP SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [REVLON]4Current NDC, Legacy NDC, 1 package rows20240113_b3ad9686-47ed-4b60-e053-2995a90abcdd.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 159 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.03b0f2ee-526b-4513-b70a-2918ad322b5e2025-11-19WarningsExact identifier
application number: M020
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEPARTICLE AESTHETIC SCIENCE LTD1b33b4fb-1deb-69f7-e063-6294a90a9cc02025-11-19WarningsExact identifier
application number: M020
Softlips VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8dff782f-7201-4ad9-94d2-672058f817b82025-11-19WarningsExact identifier
application number: M020
Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum SPF30AVOBENZONE, OXTINOXATE, OCTOCRYLENE, OXYBENZONEBaxter Laboratories Pty. Ltd.43923c68-87ad-1ab7-e063-6394a90adf7a2025-11-18WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e36351-4caf-3393-e063-6394a90a00b12025-11-18WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e454cf-dac8-4c2f-e063-6394a90a70972025-11-18WarningsExact identifier
application number: M020
Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEH.E.B.43e55eb7-6572-bd88-e063-6294a90aa7ee2025-11-18WarningsExact identifier
application number: M020
ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMerle Norman Cosmetics, Inc.d10272ea-aedd-5759-e053-2a95a90a3ab32025-11-18WarningsExact identifier
application number: M020
DAYDREAM Broad Spectrum Sunscreen SPF 40ZINC OXIDEDrmtlgy, LLCbd0981cb-49ce-4eaf-bd9e-db48f56b73142025-11-18WarningsExact identifier
application number: M020
SPF 25 LIP BALMAVOBENZONE, OCTISALATE, HOMOSALATEDrmtlgy, LLC8aed2fb0-f7b8-4ff0-b597-144c0557789e2025-11-18WarningsExact identifier
application number: M020
Sunny Defense Sunscreen StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd262450f0-c4a1-dcca-e063-6394a90ae3cd2025-11-17WarningsExact identifier
application number: M020
Tone Blur Essence SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd1814b5e7-5bbf-df16-e063-6294a90a96c42025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5bd02-62e0-019a-e063-6294a90adcf32025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5d54e-119c-0c6d-e063-6394a90aba4c2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5eb1c-b268-acfb-e063-6394a90ad4cc2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6157a-4b62-8279-e063-6294a90abe052025-11-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10967-668-011096706680132 g in 1 JAR (10967-668-01) 32 g2015-11-110000-00-00NoNoCurrent