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 214 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cicatricure Gold Lift SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGenomma Lab USA34cc5b3c-af36-e202-e063-6294a90a13a72025-05-10WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationfe19a057-a3c6-4c53-92f9-a4a960cd5b082025-05-07WarningsExact identifier
application number: M020
Winter Survival KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDuke Cannon Supply Co.2487ab56-7856-66b0-e063-6394a90a9d872025-05-07WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEAllure Labs3490ed60-60b9-dfcd-e063-6394a90ab17a2025-05-07WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Nude BeigeZINC OXIDEKoco Life LLC3491084b-348a-f2bf-e063-6394a90abd252025-05-07WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - WatermelonZINC OXIDEKoco Life LLC3491fb2a-d55f-1736-e063-6294a90a594a2025-05-07WarningsExact identifier
application number: M020
Abib Heartleaf mild sunscreen Relief tubeZINC OXIDEFOURCOMPANY CO., LTD.34965587-c9b7-4066-e063-6394a90ab4242025-05-07WarningsExact identifier
application number: M020
CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarins157cb8ca-1a36-41fb-be9e-b157b146dc4d2025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 50 SportAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutionse25e4f76-8311-491b-e053-2a95a90a4fc82025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e260b901-5918-48df-e053-2a95a90a68c32025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e25cf8e4-93cd-f5f6-e053-2995a90a45452025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 30 GallonAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e260c1bc-8b79-abc7-e053-2a95a90ae4d22025-05-06WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Pink StrawberryZINC OXIDEKoco Life LLC347e665f-cb59-ab04-e063-6394a90ad0a62025-05-06WarningsExact identifier
application number: M020
Saucd Toasted Golden Tanning SPF 15 CaramelAVOBENZONE, OCTISALATE, HOMOSALATESAUCD GENERAL TRADING COMPANYe10d41cd-e03e-401c-9024-263350b3ec2a2025-05-05WarningsExact identifier
application number: M020
Visor Clear Body Mist Hydrating Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLCb2d7639c-cbfb-4127-8ee4-7355e0d021e12025-05-05WarningsExact identifier
application number: M020
Jacket Ultimate Performance Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBALSHI MD DERMACEUTICALSd4d82c41-01da-40af-a22c-d4d57af7a2f22025-05-05WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen Butter Stick SPF 50ZINC OXIDEElemental Herbs, Inc.114c6ac8-b133-cd16-e063-6294a90ac4f92025-05-05WarningsExact 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