FDA.reportPublic FDA data

Cetaphil Daily Facial Moisturizer with suncreen SPF 35

Product NDC
0299-4113
11-digit product format
002994113
Labeler code
0299
Product ID
0299-4113_2b6cf05c-6176-47b7-8a9d-a9649ddfd633
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
28; 95; 48; 70 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0299-41130299-4113-05DDiscontinued by firm2026-10-15

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 Daily Facial Moisturizer with suncreen SPF 35
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE28 mg/mL
HOMOSALATE95 mg/mL
OCTISALATE48 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5eb347f-0d46-4de6-8f3f-9010327678edAvailable 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
0299-4113-05Cetaphil Daily Facial Moisturizer with suncreen SPF 351 in 1 CARTONLOTION14
0299-4113-05Cetaphil Daily Facial Moisturizer with suncreen SPF 3588 mL in 1 BOTTLE, PUMPLOTION884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4113CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [GALDERMA LABORATORIES, L.P.]4Current NDC, Legacy NDC, 2 package rows20231117_f5eb347f-0d46-4de6-8f3f-9010327678ed.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 51 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Natural Ice OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company29220eaa-87cb-4ebe-87db-d36288b3a9e42026-03-24WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLCf54c617f-794e-413b-b898-4a06622b4bee2026-03-24Warnings, Adverse reactionsExact identifier
application number: M020
VITAL PERFECTION UPLIFTING AND FIRMING ADVANCED DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporation7b2d15c1-b9e1-4347-b138-9883f78822b32026-03-24WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen SPF30NON- NANO ZINC OXIDEDelta Ecommerce LLC2dda185c-6ff8-953d-e063-6394a90acc532026-03-24WarningsExact identifier
application number: M020
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
application number: M020
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF30 - 01 HAZY MAUVEZINC OXIDETIRTIR USA Inc.4c92db00-59f1-ac02-e063-6394a90a7cf12026-03-23WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50The Soleil Group, LLC27d20573-0b6b-4d4b-94ca-69b476a883a72026-03-23WarningsExact identifier
application number: M020
Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.4db37efb-2d37-7428-e063-6394a90a10e42026-03-23WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen ButterZINC OXIDEElemental Herbs, Inc.ff334e9c-dd12-92bc-e053-6394a90aa24b2026-03-23WarningsExact identifier
application number: M020
All Good Tinted Mineral Sunscreen Butter SPF 50ZINC OXIDEElemental Herbs, Inc.fe2bf779-e8b3-933f-e053-6394a90a369f2026-03-23WarningsExact identifier
application number: M020
ULTRA SOOTHER DRY-TOUCH SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEskinnplus4dbc1035-c41c-308c-e063-6394a90a36c42026-03-23WarningsExact identifier
application number: M020
Daily Defense Mineral Sunscreen Serum Broad Spectrum SPF 33ZINC OXIDEEva's Esthetics0dd7cba3-bc74-4ec1-bd4a-a2f3ed533fc72026-03-23WarningsExact identifier
application number: M020
MELAO Rice Probiotics SunscreenZINC OXIDE,ETHYLHEXYL SALICYLATE,ETHYLHEXYL METHOXYCINNAMATEGuangdong Aimu Biological Technology Co., Ltd4ccaa734-83c1-611b-e063-6294a90ab3bf2026-03-21WarningsExact identifier
application number: M020
Vacation Lip Trips Desserts Pineapple Upside Down CakeAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.69022828-8226-4977-a2ca-ad8e16793a592026-03-20WarningsExact identifier
application number: M020
VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.c7794831-52d1-4d80-936d-44af18ae04722026-03-20WarningsExact identifier
application number: M020
YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral SunscreenZINC OXIDECA-Botana International4d74a36c-ff68-afd9-e063-6394a90a08f82026-03-20WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENESICOS ET CIE468d4ed2-e616-aaaf-e063-6294a90af37a2026-03-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-4113-00002994113001 BOTTLE, PUMP in 1 CARTON (0299-4113-00) / 88 mL in 1 BOTTLE, PUMP2026-08-01NoNoCurrent
0299-4113-05002994113051 BOTTLE, PUMP in 1 CARTON (0299-4113-05) > 88 mL in 1 BOTTLE, PUMP2020-11-010000-00-00NoNoCurrent
0299-4113-100029941131010 mL in 1 TUBE (0299-4113-10) 10 ml2026-08-27YesNoCurrent