DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted

Product NDC: 82240-424
11-digit product format: 822400424
Labeler code: 82240
Product ID: 82240-424_09e30a62-356e-3cff-e063-6394a90a270f
Type: HUMAN OTC DRUG
Nonproprietary name: TITANIUM DIOXIDE, ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: DERMAKA SKIN PRODUCTS
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-02
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 60; 110 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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: DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	60 mg/mL
ZINC OXIDE	110 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	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
9aa24e1f-e338-4947-a437-554fb6b227a2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82240-424-00	DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted	100 mL in 1 TUBE	CREAM	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82240-424	DERMAKA BROAD SPECTRUM SPF-42 SUNSCREEN UNTINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [DERMAKA SKIN PRODUCTS]	2	Current NDC, 1 package rows	20231116_9aa24e1f-e338-4947-a437-554fb6b227a2.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 205 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc.	84fbbb01-bb16-41a6-a53a-6e85d515ca2c	2025-07-08	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	L'Oreal USA Products, Inc.	cd69df67-5231-4a75-a9fb-a8669806a892	2025-07-08	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	fea50c84-0567-8547-e053-6394a90aafb7	2025-07-07	Warnings	Exact identifier application number: M020
24K Skin Tone Moisturizer SPF 30	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	b4f37f69-c61d-40c6-86cc-95d041b4d1b5	2025-07-07	Warnings	Exact identifier application number: M020
Vine Vera Resveratrol Cabernet Replenishing Moisture	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	c48a7346-3971-4946-b527-a5549a98e246	2025-07-07	Warnings	Exact identifier application number: M020
Lavelier Divine Day Defense Broad Spectrum SPF 30	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	1f33a93f-ae3f-4024-9d23-26b01eed1764	2025-07-03	Warnings	Exact identifier application number: M020
HIGHHEAT Sunscreen SPF 50 Performance For Athletes	AVOBENZONE, OCTISALATE, OCTOCRYLENE	DUGOUT ESSENTIALS LLC	3b7cddb5-00d2-4998-8eec-5e5a7c5a6097	2025-07-03	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CAPE COD SKIN CARE CO. INC.	39093b2d-3fbb-8378-e063-6294a90ac6d8	2025-07-03		Exact identifier application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	09ccb37b-78ee-b510-e063-6294a90a48d5	2025-07-01	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Port Jervis Laboratories, Inc.	4b442fdf-a9cf-7e5a-e063-6394a90a9e1e	2025-07-01	Warnings	Exact identifier application number: M020
Sincerely Yours Sunny Side Up Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Sincerely Yours Inc.	4c9dfa22-70f7-83f6-e063-6394a90aa8c5	2025-07-01	Warnings	Exact identifier application number: M020
Nova Bright Skin SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE	Innovation Brands Inc.	1c201147-7a54-41b5-bdf0-394e3d7efc0c	2025-07-01	Warnings	Exact identifier application number: M020
Introstem Vitiscell Facial Shield	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	65c28ed6-649d-41d9-b214-aab6ccb02dd5	2025-07-01	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Tahiti Isle	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	38d049b4-557f-724a-e063-6394a90a19b3	2025-06-30	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Tahiti Isle	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	2f74965f-3c84-0590-e063-6294a90af267	2025-06-30	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Tahiti Isle	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	38d0d165-e981-284a-e063-6294a90acace	2025-06-30	Warnings	Exact identifier application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKIN	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	a3dc6195-3011-4e7f-b1b0-0c815b11ba8d	2025-06-30	Warnings	Exact identifier application number: M020
Youth to the People Youthscreen Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE AND OCTISALATE	LOreal USA Products Inc	5712df74-5201-474b-bbfd-703f3117bd9c	2025-06-30	Warnings	Exact identifier application number: M020
BINDA Vitamin C and hyaluronic acid Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	38bff6d0-5690-3ee5-e063-6294a90a9faa	2025-06-29	Warnings	Exact identifier application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38	TITANIUM DIOXIDE	Toshiki Pigment Co., ltd.	b7162a2f-07f1-6188-e053-2995a90a8a9c	2025-06-27	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82240-424-00	82240042400	100 mL in 1 TUBE (82240-424-00)	100 ml	2023-10-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted	DERMAKA SKIN PRODUCTS	2023-11-11	HUMAN OTC DRUG LABEL	2