EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30

Product NDC: 42338-001
Requested package NDC: 42338-001-04
11-digit product format: 423380001
Labeler code: 42338
Product ID: 42338-001_30a652e0-6e3b-e676-e063-6294a90a0434
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form: LOTION
Route: TOPICAL
Labeler: Extra Shade, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-01-06
Substance: AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 30; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 17 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

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: EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	30 mg/mL
OCTINOXATE	75 mg/mL
OCTISALATE	50 mg/mL
OXYBENZONE	40 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
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
95OOS7VE0Y	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
d197dfe3-c754-4a3d-9edd-335f3fce105c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42338-001-04	2025-03-18	C162847	48780-1	9d75b9d0-4843-f424-e053-dadaa90a57ce	EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 (4 fl oz / 120 ml)
42338-001-04	2020-01-31	C162847	48780-1	9d75b9d0-4843-f424-e053-dadaa90a57ce	EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 (4 fl oz / 120 ml)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42338-001-04	EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30	1 in 1 CARTON	LOTION	1		4
42338-001-04	EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30	120 mL in 1 BOTTLE	LOTION	120		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
COCONUT	INACTIVE INGREDIENT	3RT3536DHY	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
HEDYCHIUM CORONARIUM ROOT	INACTIVE INGREDIENT	92A6N0IQN9	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
HIBISCUS ROSA-SINENSIS FLOWERING TOP	INACTIVE INGREDIENT	X9SED65819	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)	INACTIVE INGREDIENT	8136Y38GY5	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
KIWI FRUIT	INACTIVE INGREDIENT	71ES77LGJC	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
PASSIFLORA EDULIS FLOWER	INACTIVE INGREDIENT	SY49TH8VUA	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
PLANTAGO MAJOR LEAF	INACTIVE INGREDIENT	7DC28K241X	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
SAPONARIA OFFICINALIS ROOT	INACTIVE INGREDIENT	RI2K1BMA8B	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRASHADE A SUB OF VERSITILE GROUP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42338-001	EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRA SHADE, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250321_d197dfe3-c754-4a3d-9edd-335f3fce105c.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 1 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk	SPF50	Grace And Fire USA Inc.	2735ab0f-5eec-04c5-e063-6394a90aa60e	2026-10-01	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled	SPF50	Grace And Fire USA Inc.	274a0544-6c71-4d91-e063-6394a90a2247	2026-10-01	Warnings	Exact identifier application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	Trilipid Research Institute, LLC	7f34de0a-eeb3-4b71-9abd-53d03266d993	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	6a43173f-41f9-4207-a0db-53bc8db6f4a4	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	d69b4992-d7e6-4bd7-b144-0485e35818a6	2026-09-10	Warnings	Exact identifier application number: M020
Hydra Finish SPF 15	HOMOSALATE, OCTINOXATE	Guinot	4047e8ec-834a-41e6-a144-5649a7718de4	2026-09-10	Warnings	Exact identifier application number: M020
HYDRA BEAUTE SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	806d1e18-a3fc-43df-a52a-a640902d0887	2026-09-10	Warnings	Exact identifier application number: M020
Pur Confort SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	2fe0656f-f924-48da-91bf-d6f3d98e8fd9	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	51f3d6ca-3189-4380-9afb-4259ba878274	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	b0a95379-998a-4cda-bae7-63faf3d6f3c8	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Lait Solaire Corps SPF 20	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Guinot	d9d2cee0-9189-42d0-b1ab-78b97141b128	2026-09-10	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	1226 W AESTHETICS	5b0ef395-a7dd-378e-e063-6394a90a5dce	2026-09-09	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier application number: M020
Baloom 2% Panthenol Hydro Airy Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE	ARSN KOREA	5148b638-f8a4-fa8b-e063-6294a90ac208	2026-09-08	Warnings	Exact identifier application number: M020
Double-Duty Face Moisturizer	MOSITURIZING SUNSCREEN	Jack Black, LLC	672be406-e3a1-47b4-8ef6-ee2b62baae96	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Pineapple Mint	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	0862534c-5f48-4f67-a3b8-0876a667556f	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E	LIP BALM SPF25	Jack Black, LLC	88e8752d-1fbf-4e28-b79d-7c05ecdce842	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	e8730127-2d8d-4b80-ab90-d2f136d9e516	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and Ginger	LIP BALM SUNSCREEN	Jack Black, LLC	d961d22a-2125-41e9-94a3-5b53d12b320f	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Asian Pear	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	acace707-6671-4818-86f2-d9813792157a	2026-09-08	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
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42338-001-04	42338000104	1 BOTTLE in 1 CARTON (42338-001-04) / 120 mL in 1 BOTTLE	1 bottle	2012-01-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 (4 fl oz / 120 ml)	Extra Shade, LLC \| Columbia Cosmetics Manufacturing, Inc.	2025-03-18	HUMAN OTC DRUG LABEL	4