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 18 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc511f6de9-264a-4cf2-97c3-aa8adbc52a872026-06-23WarningsExact identifier
application number: M020
fmg Cashmere Lip Glaze Broad Spectrum SPF 30 SunscreenZINC OXIDETHE AVON COMPANY54f1b153-c79b-bcf8-e063-6394a90ae4262026-06-23WarningsExact identifier
application number: M020
CVS 70 Daily Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY54f25934-b4c4-4fc8-e063-6294a90a543a2026-06-23WarningsExact identifier
application number: M020
Soleil Set sunscreen SPF 50AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%The Soleil Groupcc4e4b99-5f42-4a93-a3a0-ea19f57d27832026-06-23WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY54f6d7c1-59d1-0b36-e063-6394a90a17a32026-06-23WarningsExact identifier
application number: M020
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
application number: M020
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
application number: M020
Mama and Hapa s - Bulk Sunscreen Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED54e18569-2e51-366a-e063-6394a90af8ec2026-06-22WarningsExact identifier
application number: M020
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
application number: M020
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE COCO LOCOBy the Beach Suncare LLC549be1ca-df21-a643-e063-6394a90ac0262026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL COCO LOCOBy the Beach Suncare LLC549bad35-3005-875b-e063-6394a90ad31e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL MELON DAZEBy the Beach Suncare LLC549bbd19-8e22-e420-e063-6294a90a6a982026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CANDY CLOUDSBy the Beach Suncare LLC549bd1b1-a6e2-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CITRUS CRUSHBy the Beach Suncare LLC549bd1b1-a6ee-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENSummer Soles, LLC dba Farm House Freash Goods5488fd8c-7ef2-22c2-e063-6394a90aff3c2026-06-18WarningsExact identifier
application number: M020
Stream2Sea Sport Lip Balm SPF 50ZINC OXIDEStream2Sea, LLC5489fea5-bc0e-82cf-e063-6294a90aa0972026-06-18WarningsExact identifier
application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
application number: M020
UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC4a6f9be3-2a56-8b41-e063-6294a90a30f82026-06-18WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50MINERAL SUNSCREENALAINA HEALTHCARE PRIVATE LIMITED7e036f9f-b26d-4f11-911c-c1fa854edb0f2026-06-17WarningsExact 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