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 33 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up SPF 50 Coconut Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51510195-a577-dce4-e063-6294a90a3e742026-05-08WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Watermelon Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION5151493a-c25a-fb59-e063-6394a90a10342026-05-08WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Strawberry Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51512b9f-514d-3a29-e063-6294a90ae1732026-05-08WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Peony Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION5151560f-350c-88c3-e063-6294a90a34922026-05-08WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbb65c8d7-318f-4d52-9d74-ca22ce3896382026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 CassetteCIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTELE COSMETICS INC5139cc37-62ac-514b-e063-6394a90a9ca32026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 KellyCIELE LIP AND PROTECT LIPSTICK SPF 60 KELLYLE COSMETICS INC5139d3c1-83d1-2ad9-e063-6394a90a69582026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 MargauxCIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUXLE COSMETICS INC5138eb74-0223-6c1f-e063-6294a90a3bc62026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 BonnieCIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIELE COSMETICS INC513a0449-5494-5dfd-e063-6394a90a026e2026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLouCIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOULE COSMETICS INC5139dab1-3c27-a59e-e063-6294a90a70962026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 PuzzleCIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLELE COSMETICS INC513a0722-42ab-1051-e063-6294a90a8a1d2026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 SaddleCIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLELE COSMETICS INC513a12cf-0230-6a24-e063-6394a90afb952026-05-07WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Banana Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION513bdfb1-6b90-dfc7-e063-6394a90a9ec22026-05-07WarningsExact identifier
application number: M020
Zinc Oxide 20.00%SPF 50 MINERALCoconut Caliente Costa Rica LLC388f1e01-0feb-4c94-88a7-13c81368c6c82026-05-07WarningsExact identifier
application number: M020
SPF 50 Kids SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLC9839570f-eeef-4140-a6ca-9fd2c9767a5b2026-05-07WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior67b90f00-4c82-40cd-af96-f8dedf95f8af2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7a2bd17d-0ea7-4326-9939-a747869c01d22026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora396c0eb-f91f-4732-9c20-6b25aa0634b72026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior18b21fba-f6ee-4ac5-a536-096716f51da02026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior13c34bba-f939-4aa7-9457-9d6025902e062026-05-06WarningsExact 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