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 268 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana Boat simply protect sensitive MINERAL ENRICHED SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDEEdgewell Personal Care Brands, LLC92fdea59-c19d-627a-e053-2995a90aabdc2024-11-25WarningsExact identifier
application number: M020
VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15Bobbi Brown Professional Cosmetics Inc.eecb05ab-2048-6e8d-e053-2995a90a82802024-11-22WarningsExact identifier
application number: M020
Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 HR Full Coverage SPF 18 Octinoxate Sunscreen Liquid FoundationOCTINOXATENoxell Corporation258e8f05-295e-8e32-e063-6294a90a75482024-11-21WarningsExact identifier
application number: M020
MILKY MINERAL SUN SERUMTITANIUM DIOXIDE AND ZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity53834c89-b3b4-4e21-b9f6-19f95e78ba832024-11-21WarningsExact identifier
application number: M020
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMERZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity5996f9b2-18c1-4c8f-a0ab-eca180db61ad2024-11-21WarningsExact identifier
application number: M020
NATURAL MINERAL BODY SUNSCREENZINC OXIDESynchronicity Spa, Inc. DBA Suntegritydc5116d4-3a42-44d4-b41a-e88b5b16d1112024-11-21WarningsExact identifier
application number: M020
IMPECCABLE SKIN - IVORYZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity98a7896e-4b03-4184-ac2e-6b49e47c0bc42024-11-21WarningsExact identifier
application number: M020
1177, 1178 Sunscreen1177, 1178 SUNSCREENDynarexc3142ddb-74ea-a7d1-e053-2a95a90a26f32024-11-20WarningsExact identifier
application number: M020
Covergirl Aquasmooth Broadspectrum SPF 20 All shadesTITANIUM DIOXIDENoxell Corporation952ea869-581e-4503-9f21-a77d061a417d2024-11-20WarningsExact identifier
application number: M020
Covergirl TruBlend Base Business Everyday Defense Primer SPF 20ENSULIZOLENOXELL CORPORATION8528aa01-fd4b-58a6-e053-2991aa0a3d6a2024-11-20WarningsExact identifier
application number: M020
Facial Skin Shield Broad Spectrum SPF50 PlusAVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltdbb62c700-be07-4fe3-b007-425a5f760b302024-11-20WarningsExact identifier
application number: M020
FOUNDATION LIGHT SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273ea785-241b-3e10-e063-6294a90a9fff2024-11-19WarningsExact identifier
application number: M020
FOUNDATION MEDIUM SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273f4d65-b245-c27a-e063-6394a90ade072024-11-19WarningsExact identifier
application number: M020
Pool Bar London Not Just a Pretty Face Sunscreen SPF 50ZINC OXIDEPOOLBARc081acef-9e1d-4aa6-b49c-c92fe28af2c72024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR3a481521-e209-4c86-895f-2e7392b7c5652024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 50 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR1721023c-3321-4f0b-a053-6d0c657fa1b02024-11-19WarningsExact identifier
application number: M020
Theraderm Platinum Protection Facial Sunscreen SPF 40OCTOCRYLENE, OCTISALATE, ZINC OXIDETherapon Inc1fea6ad8-4d33-4f7c-800c-1bee644bd97f2024-11-19WarningsExact identifier
application number: M020
Fresh Monster Mineral SunscreenZINC OXIDEBlue Zebra Brands, Inc.230cc36d-5163-f423-e063-6394a90a81242024-11-19WarningsExact identifier
application number: M020
Covergirl Advanced Radiance Age Defying Makeup plus Sunscreen SPF 10 (All shades)OCTINOXATE AND TITANIUM DIOXIDENoxell356af30e-82c7-4e28-94bb-b536e74d01e12024-11-19WarningsExact identifier
application number: M020
Covergirl plus Olay Simply Ageless Foundation plus Titanium Dioxide Sunscreen Broad Spectrum SPF 28 (All shades)TITANIUM DIOXIDENoxell Corporationfab59bd6-4ef6-4626-9f75-edcd4088e6432024-11-19WarningsExact 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