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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0299-4113	0299-4113-05	D	Discontinued by firm		2026-10-30

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
Ingredient	Strength
AVOBENZONE	28 mg/mL
HOMOSALATE	95 mg/mL
OCTISALATE	48 mg/mL
OCTOCRYLENE	70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f5eb347f-0d46-4de6-8f3f-9010327678ed	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0299-4113-05	Cetaphil Daily Facial Moisturizer with suncreen SPF 35	1 in 1 CARTON	LOTION	1		4
0299-4113-05	Cetaphil Daily Facial Moisturizer with suncreen SPF 35	88 mL in 1 BOTTLE, PUMP	LOTION	88		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0299-4113	CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [GALDERMA LABORATORIES, L.P.]	4	Current NDC, Legacy NDC, 2 package rows	20231117_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 280 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Market Basket Continuous Sunscreen General Protection SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	DEMOULAS SUPER MARKETS, INC.	e7182d07-a006-db4b-e053-2995a90aa9e1	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	e467df80-9007-46c9-e053-2a95a90a1bef	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT KIDS SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	e467c306-a2ed-4976-e053-2995a90a56ed	2024-10-17	Warnings	Exact identifier application number: M020
Exchange Select Sport Sunscreen Continuous SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	Army & Air Force Exchange Service	e716ba8c-0148-07f2-e053-2a95a90a53df	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	f55828b4-f2a4-13ec-e053-2995a90a0f84	2024-10-17	Warnings	Exact identifier application number: M020
SPF50 Plus Mineral Sunscreen	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	08e8bc10-85d8-4215-8351-7ec12029416c	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	9ac92c96-5bcf-421d-9cd0-73ddfa10195c	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	20b32aae-7f8b-44ed-a3df-706054fd6883	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	d77be4d0-c08a-4d81-b5df-a9bae38e3b97	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN	HOMOSALATE, OCTISALATE	FRUIT OF THE EARTH, INC.	13325a2a-f7f8-4019-acbb-205fd5dd13a5	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	ae7951e9-54f6-4eab-81b6-a2b2c978851d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Clubwith Blood Orange and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7805f3c-5b95-73bd-e053-2a95a90a9984	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Manuka Honey and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7820ba9-7520-5139-e053-2a95a90ab92d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Blood Orange and Essential Oils SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7916317-c6a2-2eda-e053-2995a90a1628	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Mentha and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c790031d-5448-a998-e053-2a95a90a763e	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of The Earth Sun Town City Kids SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c79472ea-a367-1328-e053-2a95a90a22d5	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Dark Tanning Dry Oil SPF 8 Sunscreen	HOMOSALATE, OCTISALATE	Fruit of the Earth, Inc.	c7a94f68-a4d5-ec82-e053-2995a90a38fb	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7ba72c2-ea23-0bb9-e053-2a95a90a1d90	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c795cd2f-89dc-78e3-e053-2a95a90a9422	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7a4783f-477f-1524-e053-2995a90a5ad9	2024-10-17	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0299-4113-00	00299411300	1 BOTTLE, PUMP in 1 CARTON (0299-4113-00) / 88 mL in 1 BOTTLE, PUMP		2026-08-01		No	No	Current
0299-4113-05	00299411305	1 BOTTLE, PUMP in 1 CARTON (0299-4113-05) > 88 mL in 1 BOTTLE, PUMP		2020-11-01	0000-00-00	No	No	Current
0299-4113-10	00299411310	10 mL in 1 TUBE (0299-4113-10)	10 ml	2026-08-27		Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetaphil Daily Facial Moisturizer with sunscreen SPF 35	Galderma Laboratories, L.P. \| G Production Inc.	2026-08-28	HUMAN OTC DRUG LABEL	5