Blue Lizard Sensitive Sunscreen

Product NDC: 0316-2045
Requested package NDC: 0316-2045-45
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0316-2045	0316-2045-45	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

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

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0316-2045-10	2023-02-13	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-30	2023-02-13	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-40	2023-02-13	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-45	2023-02-13	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-50	2023-02-13	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-60	2023-02-13	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-10	2023-01-30	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-30	2023-01-30	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-40	2023-01-30	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-45	2023-01-30	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-50	2023-01-30	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	Blue Lizard Sensitive
0316-2045-60	2023-01-30	C162847	48780-1	f386c64a-476f-0266-e053-dadaa90a7c1a	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 1 of 359 · 7,165 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NeoStrata Skin Active Matrix Support SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	NeoStrata Company Inc.	8e4b9c08-b906-4c5f-a243-55838ae28b90	2026-07-29	Warnings	Exact identifier application number: M020
Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	NeoStrata Company Inc.	4739e678-ce51-4863-bb74-2275879e1b47	2026-07-29	Warnings	Exact identifier application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREEN	BUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENE	Guangdong Aimu Biological Technology Co., Ltd	57a8c34a-d6c9-c03e-e063-6394a90a7af1	2026-07-29	Warnings	Exact identifier application number: M020
BelleJoss BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	57c07f29-2e23-d18a-e063-6394a90a1020	2026-07-29	Warnings	Exact identifier application number: M020
BemeJolie BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	57c27cea-bb0c-5d2d-e063-6394a90a1b48	2026-07-29	Warnings	Exact identifier application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 Unscented	ZINC OXIDE	The Procter & Gamble Manufacturing Company	3a89238b-d1ee-d7fa-e063-6294a90ae55f	2026-07-28	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	dfb1b42e-c821-1a41-e053-2995a90acf95	2026-07-28	Warnings	Exact identifier application number: M020
LUXE COLOR FOUNDATION	OCTINOXATE 7% ZINC OXIDE 5%	Guangzhou Huixue Biotechnology Co., Ltd.	576c3496-702f-808c-e063-6394a90a53c3	2026-07-25	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 Kit	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Xact Packing Limited	5759058d-e683-f3fc-e063-6394a90abc01	2026-07-24	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT	ZINC OXIDE	Younique, LLC	f93d42a9-b655-4b75-a16d-b29f38f04efc	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUM	ZINC OXIDE	Younique, LLC	82769819-b229-4864-9b3c-44f49a68a53a	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR	ZINC OXIDE	Younique, LLC	ed700cae-8226-48d9-93ba-03154aa1cae5	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHT	ZINC OXIDE	Younique, LLC	d728b89c-692f-485b-88c3-929b2f0350d5	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM	ZINC OXIDE	Younique, LLC	a49dfff1-e9ec-4573-90b0-ef6a7226aa56	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARK	ZINC OXIDE	Younique, LLC	cc576b63-caf4-491d-8d7f-027b1127133b	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK	ZINC OXIDE	Younique, LLC	2173666b-6c72-449d-9f40-098ea174f3e1	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEP	ZINC OXIDE	Younique, LLC	360ceb90-bec6-4fec-820a-a4d65008b872	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEP	ZINC OXIDE	Younique, LLC	86c33a9e-9132-4377-8688-41e5844de62c	2026-07-23	Warnings	Exact identifier application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTURE	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Forest Avenue Co., Ltd.	edbfcf21-96c6-4519-8b08-f9b5ada7d1d7	2026-07-23	Warnings	Exact identifier application number: M020
SKINSUIT LIP SPF 30	ZINC OXIDE	Skin Authority LLC	cb24d714-f6cd-4518-b146-627cfe6c2ccd	2026-07-23	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
0316-2045-45	00316204545	148 mL in 1 TUBE (0316-2045-45)	148 ml	2019-01-02	2022-11-30	No	No	Current