FDA.reportPublic FDA data

CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen

Product NDC
49967-015
11-digit product format
499670015
Labeler code
49967
Product ID
49967-015_9e408aae-0e5e-476f-aefe-3b813f3934b7
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Meradimate, Octinoxate, Zinc Oxide, and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-03
Substance
HOMOSALATE; MERADIMATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE
Active strength
100; 50; 50; 20; 63 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
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
CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
MERADIMATE50 mg/mL
OCTINOXATE50 mg/mL
OCTOCRYLENE20 mg/mL
ZINC OXIDE63 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
J9QGD60OUZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2138f86b-3937-4c2b-9568-d40a745b637dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-015-01CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen89 mL in 1 BOTTLE, PLASTICLOTION897
49967-015-01CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION17
49967-015-02CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen60 mL in 1 BOTTLE, PLASTICLOTION607
49967-015-02CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION17
49967-015-03CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen5 mL in 1 TUBELOTION57
49967-015-04CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1.5 mL in 1 PACKETLOTION1.57
49967-015-05CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION17
49967-015-05CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen50 mL in 1 BOTTLELOTION507
49967-015-06CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION17
49967-015-06CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen148 mL in 1 TUBELOTION1487

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-015CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS, INC.]7Current NDC, Legacy NDC, 10 package rows20240101_2138f86b-3937-4c2b-9568-d40a745b637d.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 209 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfecting BB Beauty Balm Natural Tint SPF 30ZINC OXIDEAndalou naturals16ca3790-9973-4a04-a43c-e0f7b384f1472025-06-11WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd.3690af2b-fe22-3a9a-e063-6294a90a709d2025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEPPacifica Beauty, LLC373901f7-0e32-0f32-e063-6394a90abe252025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TANPacifica Beauty, LLC37397b96-ef14-9098-e063-6294a90aafc92025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHTPacifica Beauty, LLC373aba7c-2ae1-8726-e063-6294a90ae3d82025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUMPacifica Beauty, LLC373c29b9-2f75-9777-e063-6394a90a68a62025-06-10WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374395ea-ab91-de70-e063-6394a90aec562025-06-10WarningsExact identifier
application number: M020
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30ZINC OXIDEAndalou naturalsaa689e82-6512-46d8-aec9-269f9348d3f82025-06-09WarningsExact identifier
application number: M020
ALLIES OF SKIN The One SPF-50 Invisible SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.36e1c61c-33ab-4a5d-853d-119c29632b082025-06-09WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTION STITANIUM DIOXIDE AND ZINC OXIDEShiseido Americas Corporationb2fae1ba-67fe-48ef-b31f-62db343499612025-06-09WarningsExact identifier
application number: M020
Olay Super Cream with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company372819f1-0813-2cd5-e063-6294a90ac5bf2025-06-09WarningsExact identifier
application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-ClearAVOBENZONE, HOMOSALATE, OCTISALATEe.l.f. Cosmetics, Inc.3806e2f2-ffd1-6d69-e063-6394a90acb442025-06-09WarningsExact identifier
application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-GetawayAVOBENZONE, HOMOSALATE, OCTISALATEe.l.f. Cosmetics, Inc.3808613f-88d6-6c1a-e063-6294a90a5bb22025-06-09WarningsExact identifier
application number: M020
1000 Roses Daily Shade Facial SPF 18OCTISALATE, OCTOCRYLENE, AND AVOBENZONEAndalou naturals0923e090-6834-4373-80fe-21f00b8c1c172025-06-09WarningsExact identifier
application number: M020
dAlba Vegan Fresh Sun CushionZINC OXIDE, HOMOSALATE, OCTOCRYLENEADMTMAX LLC20afcbab-a2f4-7965-e063-6294a90a83d12025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Mild SunscreenZINC OXIDEADMTMAX LLC20ab5698-cd9f-0821-e063-6394a90a60d72025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Fresh Sun StickHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATEADMTMAX LLC20ae82ae-bc8f-89d1-e063-6394a90afff22025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Essence SunscreenHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATEADMTMAX LLC1ccfa213-2f83-ad50-e063-6294a90a38bf2025-06-08WarningsExact identifier
application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/MediumZINC OXIDEPacifica Beauty, LLC36ec6c9d-f7dc-0419-e063-6294a90a55e62025-06-06WarningsExact identifier
application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/FairZINC OXIDEPacifica Beauty, LLC36ed9101-249a-922c-e063-6394a90a26082025-06-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-015-01499670015011 BOTTLE, PLASTIC in 1 CARTON (49967-015-01) / 89 mL in 1 BOTTLE, PLASTIC2017-08-030000-00-00NoNoCurrent
49967-015-02499670015021 BOTTLE, PLASTIC in 1 CARTON (49967-015-02) / 60 mL in 1 BOTTLE, PLASTIC2017-08-030000-00-00NoNoCurrent
49967-015-03499670015035 mL in 1 TUBE (49967-015-03) 5 ml2017-08-030000-00-00NoNoCurrent
49967-015-04499670015041.5 mL in 1 PACKET (49967-015-04) 1.5 ml2017-08-030000-00-00NoNoCurrent
49967-015-05499670015051 BOTTLE in 1 CARTON (49967-015-05) / 50 mL in 1 BOTTLE1 bottle2017-08-030000-00-00NoNoCurrent
49967-015-06499670015061 TUBE in 1 CARTON (49967-015-06) / 148 mL in 1 TUBE1 tube2017-08-030000-00-00NoNoCurrent