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 43 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.cf33c5a1-b7c5-4c5a-9981-e4e24208cd112026-04-15WarningsExact identifier
application number: M020
JAFRA SUN Facial Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.56c124d7-0b8c-4bb9-8261-c7395353fbe02026-04-15WarningsExact identifier
application number: M020
JAFRA SUN Body Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.12b64f66-0ec0-4dde-9446-4151ae001ae42026-04-15WarningsExact identifier
application number: M020
Tula 24-7 Moisture Plus SPF 30 Hydrating Day with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEPML NYC, LLC396dc7c7-a5e1-e1b2-e063-6294a90a75472026-04-15WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream115 NPML NYC, LLC316e8ac6-f8fa-7add-e063-6294a90a4f242026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f87e24f-e4ff-03a7-e063-6294a90a23b12026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo GlowYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd602-8af5-fbb6-e063-6294a90a287b2026-04-15WarningsExact identifier
application number: M020
Chanvida Broad Spectrum BB CreamCHANVIDA BROAD SPECTRUM BB CREAMGuangzhou Ariel Biotech Co., Ltd.4f8ade09-4f7a-80bd-e063-6394a90a08432026-04-15WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEGold Inti Trade Corporation4f6dd01e-21ab-0aa3-e063-6394a90a51f82026-04-14WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERBEAUTY PIE U.S.A. INC.fdefb670-510c-9f1f-e053-6394a90a6a162026-04-14WarningsExact identifier
application number: M020
DAILY SUPERGOOP DOSE BIORETINOL MINERAL SPF 40DAILY DOSE BIORETINOL MINERAL SPF 40PML NYC, LLC05574910-ddf9-b138-e063-6394a90adc8c2026-04-14WarningsExact identifier
application number: M020
ProtecTINT 20CHOMOSALATE, OCTISALATE, ZINC OXIDEPML NYC, LLC1bcc9f71-820f-eba2-e063-6394a90a33052026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c0f2d9-3e2f-5358-e053-2995a90aeb842026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c2a37d-f52d-2fb0-e053-2a95a90a9bfa2026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c3b1ef-0eae-6ac7-e053-2a95a90ac1dc2026-04-14WarningsExact identifier
application number: M020
NATURIUM Dew-Glow Moisturizer SPF 50NATURIUM DEW-GLOW MOISTURIZER SPF 50PML NYC, LLC00c93b11-754e-701c-e063-6294a90a3b1d2026-04-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEPML NYC, LLC1c3489a6-5b98-2dc2-e063-6294a90a06952026-04-14WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONELongway Technology(Guangzhou)Co.,Ltd.4f2c83e4-e656-f81e-e063-6394a90a4c682026-04-11WarningsExact 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