FDA.reportPublic FDA data

Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30

Product NDC
0299-4136
11-digit product format
002994136
Labeler code
0299
Product ID
0299-4136_d539895d-e516-438e-854f-9b48cc3eb154
Type
HUMAN OTC DRUG
Nonproprietary name
homosalate, octocrylene, octisalate, avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-12
Substance
HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
95; 95; 48; 28 mg/g; mg/g; 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
Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE95 mg/g
OCTOCRYLENE95 mg/g
OCTISALATE48 mg/g
AVOBENZONE28 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b4e25ad-cd72-4960-9259-fc710bfd59daAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4136-00Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 301 in 1 CARTONLOTION13
0299-4136-00Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 3048 g in 1 TUBELOTION483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4136CETAPHIL HEALTHY RENEW DAY CREAM BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3Current NDC, 2 package rows20250130_5b4e25ad-cd72-4960-9259-fc710bfd59da.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 276 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health 60 Plus Sensitive Skin SunTITANIUM DIOXIDE, ZINC OXIDECVS Pharmacy477c25ec-33db-04a6-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4eb75945-9d65-55b4-e054-00144ff88e882024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,CVS Pharmacy4ec6384a-8faf-5712-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 30 ClearAVOBENZONE, HOMOSALATE, OCTOCRYLENE,CVS Pharmacy4ec6b50b-5236-6f5b-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Pharmacy SPF 70 Beach Guard ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4ec75d23-a33b-6c52-e054-00144ff88e882024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 Beach Guard SunAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4adbd66a-6b38-046d-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 100 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy651c245c-2d3a-0019-e053-2991aa0a46372024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 SunAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy63b420ba-ac69-5670-e053-2a91aa0a864b2024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS PHARMACYc52a7e9b-5401-f6e7-e053-2995a90a95192024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyc68c3d6a-b656-abaf-e053-2a95a90a48db2024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 45 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyc5e8fcc9-db5c-9ee7-e053-2a95a90ac9402024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 55 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyc617cdec-b489-22d2-e053-2995a90a1ec62024-10-22WarningsExact identifier
application number: M020
TRADER JOES ILLUMINATING DAILY FACIAL SUNSCREEN BROAD SPECTRUM SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company1b7c2f13-81b8-7af5-e063-6294a90a35012024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 50 Beach GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacydf25c35d-6b6d-1ef8-e053-2995a90aaef52024-10-22WarningsExact identifier
application number: M020
CVS Health Kids SPF 50 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYe4581d0e-ce6d-7898-e053-2a95a90a02b52024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 55 Ultra Sheer Face MistAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacydfb55b46-e88f-4949-e053-2995a90adabc2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 30 Clear Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENECVS PHARMACYe4589114-87c5-56b8-e053-2995a90a09342024-10-22WarningsExact identifier
application number: M020
TRADER JOES ENRICH MOISTURIZING FACE BROAD SPECTRUM SPF 15OCTINOXATE, ZINC OXIDETrader Joe's Companya6805675-916c-4a19-b993-d465fcef58a12024-10-22WarningsExact identifier
application number: M020
TRADER JOES FACE AND BODY SUNSCREEN SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company057ac99c-60e8-47c1-a32d-984bbd1818462024-10-22WarningsExact identifier
application number: M020
TRADER JOES ZINC OXIDE MINERAL SUNSCREEN SPF 30ZINC OXIDETrader Joe's Company9e48de83-cb72-4c03-a819-939db8793e1f2024-10-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0299-4136-00002994136001 TUBE in 1 CARTON (0299-4136-00) / 48 g in 1 TUBE1 tube2023-04-12NoNoCurrent