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 229 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fre Glow Me Lightweight Tinted Moisturizer Medium DeepZINC OXIDEPeer Pharm Ltd.45ed56e1-46cb-46de-b11a-e814a7446e572025-02-13WarningsExact identifier
application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Light MediumZINC OXIDEPeer Pharm Ltd.6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a2025-02-13WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe99311c2-ed8b-6e60-e053-2a95a90a9bc22025-02-13WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC525f7bae-44b8-44e4-93ea-32995eca25662025-02-13WarningsExact identifier
application number: M020
DreamBeam Sunscreen SunlitSUNSCREEN ZINC OXIDEKosas Cosmetics, LLC2e093b82-2a36-cc0f-e063-6394a90a4d6d2025-02-13WarningsExact identifier
application number: M020
DreamBeam SunscreenSUNSCREEN ZINC OXIDEKosas Cosmetics, LLCf93b0091-6a41-ae6e-e053-6394a90a86d72025-02-13WarningsExact identifier
application number: M020
Revealer Skin-Improving FoundationSUNSCREEN ZINC OXIDEKosas Cosmetics, LLC2e0a0cd6-c302-2017-e063-6394a90a60b82025-02-13WarningsExact identifier
application number: M020
Hi papa KIDS MINERAL FACE SUNSCREENSUNSCREENGUANG DONG 3 INS TECHNOLOGY Co., Ltd2deea723-32a0-da33-e063-6294a90accdd2025-02-12WarningsExact identifier
application number: M020
Quick Screen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Quick Flick PTY LTD3788666e-7efa-43da-95f5-6218b7fcb6ea2025-02-12WarningsExact identifier
application number: M020
Dolce AND Gabbana Get Your Healthy Glowy SkinZINC OXIDESocoplan91bf1cca-8d18-4c59-864d-4fd0619c67132025-02-12WarningsExact identifier
application number: M020
Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dfd1f99-5896-1e0f-e063-6394a90aa71d2025-02-12WarningsExact identifier
application number: M020
Biore Aqua Rich UVOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USAf9024581-dbab-b7cb-e053-6294a90a8b9a2025-02-12WarningsExact identifier
application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLCebdaf6c1-1572-4840-851b-6d780471fcb22025-02-11WarningsExact identifier
application number: M020
Sky and Sol Body Sunscreen SPF50SKY AND SOL BODY SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd2de9173b-fa02-8017-e063-6394a90ae0aa2025-02-11WarningsExact identifier
application number: M020
Beeswax SPF 15 Broad Spectrum Lip BalmBEESWAX SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc2dcc2f9b-4a8c-b281-e063-6294a90ad9d62025-02-10WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Tropical SunscreenBROAD SPECTRUM SPF 30 TROPICAL SUNSCREENRaining Rose, Inc2dcca380-c0e4-4e04-e063-6394a90ac31e2025-02-10WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp88021a24-d3b5-48f8-8d26-affbfcfd098f2025-02-10WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2dd20800-2cf9-02d4-e063-6294a90a0f002025-02-10WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2dd5ea23-eee6-5d14-e063-6294a90a0fd32025-02-10WarningsExact identifier
application number: M020
Centella Calming SUNSCREENCENTELLA CALMING SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2dc0ee9b-d58b-fe40-e063-6394a90af4392025-02-09WarningsExact 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