Cetaphil

Product NDC: 0299-3928
11-digit product format: 002993928
Labeler code: 0299
Product ID: 0299-3928_8731dd5b-3ac1-42f8-b510-68f3e5104038
Type: HUMAN OTC DRUG
Nonproprietary name: octocrylene, avobenzone
Dosage form: LOTION
Route: TOPICAL
Labeler: Galderma Laboratories, L.P.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2000-04-01
Substance: OCTOCRYLENE; AVOBENZONE
Active strength: 10; 3 g/100mL; g/100mL
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTOCRYLENE	10 g/100mL
AVOBENZONE	3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5A68WGF6WM	Internal UNII lookup
G63QQF2NOX	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
2a6bc3f2-4e52-252b-d051-94be1ee0cc00	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0299-3928-04	Cetaphil	1 in 1 CARTON	LOTION	1		10
0299-3928-04	Cetaphil	118 mL in 1 BOTTLE, PUMP	LOTION	118		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0299-3928-04	ML - Milliliter	0299-3928	293420d2-be3d-4985-a4d3-6d7bbf44a8cf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Carbomer Copolymer Type A	INACTIVE INGREDIENT	71DD5V995L	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Carbomer Homopolymer Type C	INACTIVE INGREDIENT	4Q93RCW27E	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Cyclomethicone	INACTIVE INGREDIENT	NMQ347994Z	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Diisopropyl Adipate	INACTIVE INGREDIENT	P7E6YFV72X	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Polyoxyl 100 Stearate	INACTIVE INGREDIENT	YD01N1999R	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0299-3928	CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]	10	Current NDC, Legacy NDC, 2 package rows	20240418_2a6bc3f2-4e52-252b-d051-94be1ee0cc00.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 190 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Sandbar	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3ac57c70-9298-cbe7-e063-6394a90aefc1	2025-08-27	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Tinted Sunscreen Face	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a290aad-7f40-cb10-e063-6394a90a2e69	2025-08-27	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 sunscreen	HOMOSALATE 7.5%, OCTISALATE 5.0%, AVOBENZONE 3.0%	Florida Squeezed	a01f0ab9-d686-4ee1-be39-fd4c061cb018	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen Face Stick	ZINC OXIDE	Sun Bum, LLC	3d48d467-4b6b-c477-e063-6294a90a5a0d	2025-08-26	Warnings	Exact identifier application number: M020
PAPATUI Facial Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	PAPATUI, LLC	3d4ab3a5-a29b-bdd9-e063-6294a90a542c	2025-08-26	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 50 sunscreen	HOMOSALATE 10%, OCTISALATE 5.0%, AVOBENZONE 3.0%	Florida Squeezed	34ffc25c-16e3-4c7c-9d46-9d9f279c074b	2025-08-26	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	36da7117-1c8e-7fcf-e063-6294a90aed00	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	36dc7c13-eaf7-b415-e063-6294a90a5784	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum Face 50 Premium Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c1b7f0c-fdc2-df22-e063-6294a90aed41	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum Mist 45 Refreshing Sunscreen 3.4 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c1c8b83-f37d-a29d-e063-6294a90a20a8	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum 15 Premium Sunscreen Tanning Oil	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c468710-ca71-79be-e063-6394a90a8cfd	2025-08-26	Warnings	Exact identifier application number: M020
Coco and Eve Sunny Honey Protect SPF 50 Highlighter Body SPF 50	SUNSCREEN	Soleil Collective LLC	3d4c90e7-0716-4d57-e063-6394a90a43fa	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum 70 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c4433e2-d383-8326-e063-6294a90aaf98	2025-08-26	Warnings	Exact identifier application number: M020
Coco and Eve Sunny Honey Protect SPF 50 Coconut Milk Body SPF 50	SUNSCREEN	Soleil Collective LLC	3d4d1b94-b1ce-cf94-e063-6394a90a61ba	2025-08-26	Warnings	Exact identifier application number: M020
naked TURTLE 30	ZINC OXIDE	NAKED TURTLE SUNSCREEN LLC	65f1570a-6156-40e6-a792-e0707607dc2f	2025-08-26	Warnings	Exact identifier application number: M020
Sky and Sol Sunscreen SPF 50	ZINC OXIDE	Delta Ecommerce LLC	2d490531-af38-87d0-e063-6394a90acf49	2025-08-25	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	20d24c9d-9558-156d-e063-6294a90a2d1a	2025-08-25	Warnings	Exact identifier application number: M020
Neutrogena Sport Face Oil Free Sunscreen Broad Spectrum SPF 70 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	413275e8-0011-471e-9539-ea95ed838413	2025-08-25	Warnings	Exact identifier application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - Banana	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3d34d144-2515-d7fa-e063-6294a90abb3f	2025-08-25	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 sunscreen	AVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 8.0%	Florida Squeezed	393b59aa-6d5a-4757-9f6d-59f7533aee86	2025-08-25	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0299-3928-04	00299392804	1 BOTTLE, PUMP in 1 CARTON (0299-3928-04) / 118 mL in 1 BOTTLE, PUMP	2000-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetaphil® Daily Facial Moisturizer	Galderma Laboratories, L.P. \| G Production Inc.	2024-04-16	HUMAN OTC DRUG LABEL	10