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 5 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	5990fe66-4fa2-06aa-e063-6294a90a5261	2026-08-21	Warnings	Exact identifier application number: M020
Hawaiian Tropic	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	5991466a-e729-16b7-e063-6394a90a11ff	2026-08-21	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	597b78df-83cb-1b21-e063-6294a90a56a8	2026-08-20	Warnings, Adverse reactions	Exact identifier application number: M020
Sunski Base Camp Face and Body Sunscreen SPF 45	HOMOSALATE, OCTISALATE, AVOBENZONE	Stewart Charley Ventures, LLC	2fc45f85-a6f8-4893-8b34-4db5e39cb615	2026-08-20	Warnings	Exact identifier application number: M020
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	Concierge Choice LLC	5980055b-493e-4763-e063-6294a90a570f	2026-08-20	Warnings	Exact identifier application number: M020
Lip Balm SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Skin Script, LLC	20c5fde7-ee8f-4b74-e063-6394a90a93ec	2026-08-19	Warnings	Exact identifier application number: M020
Aloe UP .5OZ SPF 50 MINERAL Sunscreen	ZINC OXIDE 14.69%	Aloe Care International, LLC	6ad80af3-78cd-4211-a5f2-68531aae264a	2026-08-19	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-Stick	ZINC OXIDE	Utu Co	596e17d3-3064-1cda-e063-6294a90af963	2026-08-19	Warnings	Exact identifier application number: M020
Mineral sunscreen	MINERAL SUNSCREEN	Guangzhou Origin Beauty Cosmetics Co., Ltd.	59713657-a7ef-1aee-e063-6394a90a326e	2026-08-19	Warnings	Exact identifier application number: M020
The Naked Bee SPF 50 Mineral Sunscreen	ZINC OXIDE 14.69%	The Naked Bee	f820a9be-c94d-4fd5-b202-2dda5746a82a	2026-08-18	Warnings	Exact identifier application number: M020
The Naked Bee SPF 50 Mineral Sunscreen	ZINC OXIDE 20%	The Naked Bee	7dd2b1cd-e229-4eeb-8122-46fde5af1091	2026-08-18	Warnings	Exact identifier application number: M020
Sun Zapper - Baby pure zinc sunscreen SPF30	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	3ee52faa-64a8-4bdf-e063-6294a90a65cf	2026-08-17	Warnings	Exact identifier application number: M020
Sun Zapper - Face pure zinc sunscreen SPF30	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	3ee4feb3-6966-67f9-e063-6394a90a16d5	2026-08-17	Warnings	Exact identifier application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier application number: M020
Soleil Defense Sunscreen	BROAD SPECTRUM SPF 30	AMARA MED SPA LLC	594244b1-db3b-002b-e063-6394a90a0329	2026-08-17	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier application number: M020
Protect Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Opal Day Spa	5943413a-48e1-0bdf-e063-6294a90a2fff	2026-08-17	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	MedSpa By Beauty Bar LLC	5943ba3d-688e-9e9c-e063-6294a90afa9a	2026-08-17	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	Charleston Dermatology, P.C.	59440f7f-4213-6e2b-e063-6394a90af483	2026-08-17	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