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 85 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
100% Mineral Broad Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd6fcc065-cbcd-0b81-e053-2a95a90ab1f92026-01-09WarningsExact identifier
application number: M020
Glow Screen Body Broad Spectrum Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb9590938-417d-617a-e053-2995a90a74962026-01-09WarningsExact identifier
application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd7758651-c152-5868-e053-2a95a90ab6732026-01-09WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 30ZINC OXIDESupergoop, LLC4cf243b4-d794-401a-b209-18c7e550ef4f2026-01-09WarningsExact identifier
application number: M020
Daily Dose Bioretinol Mineral SPF 40ZINC OXIDESupergoop, LLCeb5bbc70-dbdf-06a8-e053-2995a90a66c12026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Body SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCec1c30bd-76e1-9d00-e053-2a95a90a17592026-01-09WarningsExact identifier
application number: M020
Glow Screen SPF 40AVOBENZONE, OCTISALATE, OCTOCYLENESupergoop, LLC21569637-332a-461b-bf6c-33af6a83a1552026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 - DawnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf07145d5-b74d-7757-e053-2a95a90ac4c02026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 -SunsetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf7e493da-8fc6-191d-e053-6294a90aa4832026-01-09WarningsExact identifier
application number: M020
Supergoop Glow Screen SPF 40 Shade 2 Golden HourBROAD SPECTRUM SUNSCREENSupergoop LLCd2928dd7-a813-4929-e053-2a95a90aaeb42026-01-09WarningsExact identifier
application number: M020
Superscreen Hydrating Daily Cream SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCff0e4e97-8f01-bd36-e053-6394a90a47ae2026-01-09WarningsExact identifier
application number: M020
Lipshade SPF 30 Hey YallZINC OXIDESupergoop, LLCf93dfa13-ff18-ee38-e053-6394a90aea462026-01-09WarningsExact identifier
application number: M020
Triple Prep SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATESupergoop, LLC004df4e5-dba9-6030-e063-6394a90a76d32026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC12605fb4-0de6-94f3-e063-6294a90a3a6f2026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Stick SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC2735c5c7-a4ef-33c3-e063-6294a90abf972026-01-09WarningsExact identifier
application number: M020
PLAY Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONESupergoop LLC2860d42c-d644-8b5a-e063-6394a90aec102026-01-09WarningsExact identifier
application number: M020
PLAY Mineral SPF 30 with Green AlgaeZINC OXIDESupergoop LLC29a1ff4b-3875-5275-e063-6394a90a53fd2026-01-09WarningsExact identifier
application number: M020
Every. Single. Face. Watery SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCd086a9b8-19e5-f713-e053-2995a90aa9762026-01-09WarningsExact identifier
application number: M020
3D Tinted Moisturizing BS SPF 30ZINC OXIDEAllure Labs47fd415f-819e-bbb8-e063-6394a90a2c6a2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE BODY SUNSCREEN SPF50SUNCARE BODY SUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.4801cfd2-1fe2-d118-e063-6294a90a6c8b2026-01-09WarningsExact 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