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 77 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior166e293f-3874-4fe6-8c20-2162b0d11cf12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb048c7a5-8a71-47ea-945c-44a2d663dfa72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore0463aa0-8e56-4dcd-8cd8-776e8a3915f22026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 10N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior038939d6-b9a5-4cb6-a818-6f7cf3f106fa2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior03c7ca69-86f1-420c-9c4c-0bf2e8553c942026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorff6a85a4-b0c5-4c2e-a698-bb315203f51b2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior262b4cfc-71c3-485e-906f-a88fe33035a82026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30964b87-1d7c-4dd1-8ab2-bf9b8eb2ee032026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2cb4bad3-57d6-4e67-88ec-1776870c3eba2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00 NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorffd1ba9e-dd64-422a-bd69-596b5d80554d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64943a01-5193-4c04-b623-33ceb09f10fd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diordf2e2d3f-8876-4197-bdfa-339b4f6a75712026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb5d7fa-4d40-46bd-9ef3-14368578cb332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorae1e74f1-eb31-4da1-8b24-dae692d3637e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora5ce5568-708a-4af1-aa06-ea643c898bb12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4fc4ce51-000a-42ee-952f-b4ce5f5d8a602026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorade16145-5267-4f01-bd99-f507087583f32026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4b23d8e4-b0c3-44d7-b239-a2c7ae442a2d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72471612-1ae0-493c-87c7-bf7257310e702026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior881ad126-d93f-4782-8ece-600d41a254d72026-01-16WarningsExact 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