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 56 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.14b9ec0e-6fff-44b1-e063-6394a90aab972026-03-05WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.4c35fbbc-a79d-318f-e063-6394a90a30a72026-03-04WarningsExact identifier
application number: M020
Kids Mineral Sunscreen Stick SPF 50ZINC OXIDESmalls Brand LLC DBA Roe Wellness4c37855b-08c0-0aa7-e063-6394a90a88422026-03-04WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Incbe03b588-afbd-41d1-be96-444d735c97682026-03-03WarningsExact identifier
application number: M020
UNME SOULMA CENTELLA and BEEF TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ZINC OXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACIDShenzhen Jufeng Qiyuan Trading Co., Ltd.4c1a3345-58c1-93c8-e063-6394a90a865e2026-03-03WarningsExact identifier
application number: M020
Botnia Gentle Sun SPF 30ZINC OXIDEBotnia, Inc005d0245-fe53-47e5-888b-683f58cd6d262026-03-03WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.64534ec3-396c-4c11-9ec1-e2615f7e24b12026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.9b7249e4-4c1f-40e7-a657-d40c53d9317f2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenSUNSCREENOld East Main Co.1673b8b1-08ad-40a5-8180-93333a8edb672026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.32036e41-2414-4498-8e1c-61511abf7a322026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 100AVOBENZONE HOMOSALATE OCTISALATEOld East Main Co.42266fa5-5f30-2a9f-e063-6394a90a1dfe2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAmazon.com Services LLCd4b4ebac-c6c2-474b-afc6-b80b8431e90f2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Fruit Snack SPF 15 Broad Spectrum Lip BalmFRUIT SNACK SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc24c2a9fc-892b-c74d-e063-6394a90af62c2026-03-03WarningsExact identifier
application number: M020
Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4c231aa1-75eb-c171-e063-6294a90a8b8b2026-03-03WarningsExact identifier
application number: M020
SPF 30 Mineral SunscreenZINC OXIDESmalls Brand LLC DBA Roe Wellness4c25b4ec-b045-7066-e063-6294a90ab8012026-03-03WarningsExact identifier
application number: M020
Good Weather Skin Daily Lip Sun Gloss SPF 30 Iced CoffeeZINC OXIDEGood Weather Inc.4c261e88-7f37-2361-e063-6294a90aa6022026-03-03WarningsExact identifier
application number: M020
Good Weather Skin All Over Sun Milk Face and Body SPF 50ZINC OXIDEGood Weather Inc.4c278acc-7cd5-0d85-e063-6394a90a3a722026-03-03WarningsExact identifier
application number: M020
Lekura - ZincDaily Natural Face Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4c2bed23-f77b-2c97-e063-6394a90a4ca52026-03-03WarningsExact identifier
application number: M020
NEOGEN DERMALOGY DAY-LIGHT PROTECTION AIRY SUNSCREEN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEOUTIN FUTURES CO.,LTD.4ddce1f0-44a3-7e0c-e063-6294a90a3f7d2026-03-03WarningsExact identifier
application number: M020
Bephor Reviving Suncream SPF50ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, ZINC OXIDEGyeongbuk Institute of IT Convergence Industry Technology4c055b22-94e9-ff0d-e063-6394a90ab2ec2026-03-02WarningsExact 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