Blue Lizard Sensitive Sunscreen

Product NDC: 0316-2045
11-digit product format: 003162045
Labeler code: 0316
Product ID: 0316-2045_48345730-de18-7fb2-e063-6394a90a9b5d
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Crown Laboratories
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2003-12-08
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 54; 108 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0316-2045	0316-2045-30	D	Discontinued by firm	2026-10-12
excluded package	package	0316-2045	0316-2045-45	D	Discontinued by firm	2026-10-12
excluded package	package	0316-2045	0316-2045-50	D	Discontinued by firm	2026-10-12
excluded package	package	0316-2045	0316-2045-60	D	Discontinued by firm	2026-10-12

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 · 35 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0316-2045-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0316-2045-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0316-2045-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0316-2045-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0316-2045-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0316-2045-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0316-2045-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0316-2045-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0316-2045-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0316-2045-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0316-2045-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0316-2045-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0316-2045-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0316-2045-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0316-2045-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0316-2045-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0316-2045-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0316-2045-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0316-2045-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0316-2045-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0316-2045-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0316-2045-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0316-2045-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0316-2045-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0316-2045-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0316-2045-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0316-2045-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0316-2045-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0316-2045-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0316-2045-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0316-2045-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0316-2045-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0316-2045-45	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0316-2045-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0316-2045-45	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Blue Lizard Sensitive Sunscreen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	54 mg/mL
ZINC OXIDE	108 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
1e4d49f4-9e77-48b5-bce5-ff04ed885a0f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0316-2045-10	2023-02-13	Blue Lizard Sensitive
0316-2045-30	2023-02-13	Blue Lizard Sensitive
0316-2045-40	2023-02-13	Blue Lizard Sensitive
0316-2045-45	2023-02-13	Blue Lizard Sensitive
0316-2045-50	2023-02-13	Blue Lizard Sensitive
0316-2045-60	2023-02-13	Blue Lizard Sensitive
0316-2045-10	2023-01-30	Blue Lizard Sensitive
0316-2045-30	2023-01-30	Blue Lizard Sensitive
0316-2045-40	2023-01-30	Blue Lizard Sensitive
0316-2045-45	2023-01-30	Blue Lizard Sensitive
0316-2045-50	2023-01-30	Blue Lizard Sensitive
0316-2045-60	2023-01-30	Blue Lizard Sensitive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0316-2045-10	Blue Lizard Sensitive Sunscreen	5 mL in 1 PACKET	LOTION	5	19
0316-2045-30	Blue Lizard Sensitive Sunscreen	89 mL in 1 TUBE	LOTION	89	19
0316-2045-40	Blue Lizard Sensitive Sunscreen	148 mL in 1 BOTTLE, PLASTIC	LOTION	148	19
0316-2045-45	Blue Lizard Sensitive Sunscreen	148 mL in 1 TUBE	LOTION	148	19
0316-2045-50	Blue Lizard Sensitive Sunscreen	259 mL in 1 BOTTLE, PLASTIC	LOTION	259	19
0316-2045-60	Blue Lizard Sensitive Sunscreen	3785 mL in 1 JUG	LOTION	3785	19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)	INACTIVE INGREDIENT	035JKJ76MT	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
ETHYLHEXYL STEARATE	INACTIVE INGREDIENT	EG3PA2K3K5	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)	INACTIVE INGREDIENT	AG75W62QYU	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
METHYL GLUCOSE DIOLEATE	INACTIVE INGREDIENT	FA9KFJ4Z6P	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
OCTYLDODECYL NEOPENTANOATE	INACTIVE INGREDIENT	X8725R883T	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
PEG-7 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	WE09129TH5	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
PROPANEDIOL	INACTIVE INGREDIENT	5965N8W85T	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)	INACTIVE INGREDIENT	25LXE464L2	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0316-2045	BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	17	Current NDC, Legacy NDC, 6 package rows	20241127_1e4d49f4-9e77-48b5-bce5-ff04ed885a0f.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 7 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	22aa46af-5d0f-4256-8f45-be06f6627561	2026-08-10	Warnings	Exact identifier application number: M020
Colorescience Total Protection No Show Mineral Body Shield	ZINC OXIDE	Colorescience	52e1f59e-63cb-7480-e063-6394a90ad7c5	2026-08-10	Warnings	Exact identifier application number: M020
Eucerin Radiant Tone Tinted Sunscreen SPF 50	AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	596a4204-3d29-9023-e063-6294a90ad99e	2026-08-10	Warnings	Exact identifier application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Merz North America, Inc.	d4d4bfcf-3674-4847-8ad8-1716a8e821ae	2026-08-10	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen	BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE	Grace and Fire USA Inc.	56ad0dce-410e-9d78-e063-6294a90a1c3e	2026-08-09	Warnings	Exact identifier application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex Sunscreen	ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE	Guangzhou Yapheon Health Industry Co., Ltd.	552a36ed-7a66-4048-e063-6394a90a09bc	2026-08-08	Warnings	Exact identifier application number: M020
lip balm SPF15( 2533) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5870aa44-1375-cdc5-e063-6394a90af4a5	2026-08-07	Warnings	Exact identifier application number: M020
lip balm SPF15( Zinc oxide) 01	ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5871ab1d-cf07-d737-e063-6394a90a58fe	2026-08-07	Warnings	Exact identifier application number: M020
VEIRFOO Brightening Hydrating Antiwrinkle Sunscreen	TITANIUM DIOXIDE, OCTINOXATE	LCM TECHNOLOGY Co., Ltd	4cbbf8aa-8910-b7e7-e063-6294a90a4f07	2026-08-07	Warnings	Exact identifier application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATE	AVOBENZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	58636012-7e29-7206-e063-6394a90a83e9	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATE	AVOBENZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	5864275d-a480-06f8-e063-6394a90aecab	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	5864881c-c495-1f32-e063-6294a90a1304	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40	ZINC OXIDE	CP Skin Health Group, Inc	945538b5-5745-42cf-b610-0018ca2ec254	2026-08-06	Warnings	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	58653d79-8fff-f319-e063-6294a90af7a3	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	5865f0e5-14b2-c4bf-e063-6294a90a4710	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Stream2Sea Ecostock SPF 40 Sunscreen	ZINC OXIDE	Stream2Sea, LLC	5866e026-a652-3300-e063-6394a90acff0	2026-08-06	Warnings	Exact identifier application number: M020
NHLMA Skin Defense Sunscreen	BROAD SPECTRUM SPF 30	NATIONAL HAIR LOSS LLC	56326ae0-387f-ad08-e063-6294a90acc4f	2026-08-06	Warnings	Exact identifier application number: M020
EltaMD UV Restore	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	37fee381-ce6b-4949-9a4a-778aa839fb84	2026-08-06	Warnings	Exact identifier application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Kenvue Brands LLC	129ae274-0094-be5e-e063-6394a90a9801	2026-08-05	Warnings	Exact identifier application number: M020
Leader Kids Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH 110, LLC. DBA LEADER	3636693a-ba81-5d49-e063-6394a90a3006	2026-08-05	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	Marketing end	Sample	Exclude flag	Status
0316-2045-10	00316204510	5 mL in 1 PACKET (0316-2045-10)	5 ml	2004-04-01	0000-00-00	No	No	Current
0316-2045-30	00316204530	89 mL in 1 TUBE (0316-2045-30)	89 ml	2006-01-03	0000-00-00	No	No	Current
0316-2045-40	00316204540	148 mL in 1 BOTTLE, PLASTIC (0316-2045-40)	148 ml	2003-12-08	0000-00-00	No	No	Current
0316-2045-45	00316204545	148 mL in 1 TUBE (0316-2045-45)	148 ml	2019-01-02	0000-00-00	No	No	Current
0316-2045-50	00316204550	259 mL in 1 BOTTLE, PLASTIC (0316-2045-50)	259 ml	2005-01-03	0000-00-00	No	No	Current
0316-2045-60	00316204560	3785 mL in 1 JUG (0316-2045-60)	3785 ml	2004-02-02	0000-00-00	No	No	Current