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 37 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF Lip ColourZINC OXIDELauren Brooke Cosmetiques, LLC50b344b5-e39d-48ef-e063-6394a90ae41c2026-04-30WarningsExact identifier
application number: M020
No 7 Prime Forever SPF 50 PrimerNO 7 PRIME FOREVER BROAD SPECTRUM SUNSCREEN SPF50 PRIMERBoots Retail USA50b3e9fa-faf8-0026-e063-6294a90a08232026-04-30WarningsExact identifier
application number: M020
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
application number: M020
Moisture Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilcb95975f-060d-23c2-e053-2a95a90adf1b2026-04-30WarningsExact identifier
application number: M020
Day Cream SPF 30OCTOCRYLENE, OCTINOXATE, AVOBENZONEAnthony Skin LLC5070e8cc-12c0-c2c4-e063-6294a90a14222026-04-29WarningsExact identifier
application number: M020
Steak n Shake Beef Tallow Sunscreen SPF 30ZINC OXIDEHRR Enterprises, Inc0eb122d8-6826-4843-bed1-9e0cb8316e6d2026-04-29WarningsExact identifier
application number: M020
EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart509b6c7d-8a28-2d3a-e063-6394a90af0682026-04-29WarningsExact identifier
application number: M020
Freaks of Nature Solar Shield Broad Spectrum SPF 30FREAKS OF NATURE SOLAR SHIELD BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.509b8610-6dbe-611f-e063-6394a90a9fd12026-04-29WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
application number: M020
COTZ FACE MOISTUREZINC OXIDEFallien Cosmeceuticals Ltd.509d9a74-bc8d-c9c1-e063-6394a90a403d2026-04-29WarningsExact identifier
application number: M020
JMSOLUTION MARINE LUMINOUS PEARL SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGPNY CORP212d4563-2fad-31a5-e063-6394a90aff712026-04-29WarningsExact identifier
application number: M020
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Bronze Cell OX Shield Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc5e19577b-9911-4fa1-a2b7-7ca2e02d1fd82026-04-28WarningsExact identifier
application number: M020
Daily Defence Moisturising Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUltraceuticals Pty Ltd50888d3f-46ae-e2c2-e063-6394a90ad6af2026-04-28WarningsExact identifier
application number: M020
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
application number: M020
Fusion Water MagicOCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEISDIN Corp.d4f91d5a-600a-4255-a6e1-e7e7197848c72026-04-28WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Pearl Cell OX Shield Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc6a1b995-1898-4a92-b128-7d5ebd6d8d3d2026-04-28WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC53023b16-8d64-4dfc-bc75-b4f248425c4d2026-04-27WarningsExact identifier
application number: M020
TONEfitSUN Sebum Control Vegan SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory506b96ae-eb2a-edad-e063-6294a90a470e2026-04-27WarningsExact 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