Blue Lizard Baby

Product NDC: 0316-2035
11-digit product format: 003162035
Labeler code: 0316
Product ID: 0316-2035_ce185945-5955-c1b3-e053-2a95a90a8908
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Crown Laboratories
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2003-12-08
Marketing end: 2024-02-29
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 54 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0316-2035		D	Discontinued by firm	2026-10-05
excluded package	package	0316-2035	0316-2035-10	D	Discontinued by firm	2026-10-05
excluded package	package	0316-2035	0316-2035-30	D	Discontinued by firm	2026-10-05
excluded package	package	0316-2035	0316-2035-40	D	Discontinued by firm	2026-10-05
excluded package	package	0316-2035	0316-2035-45	D	Discontinued by firm	2026-10-05
excluded package	package	0316-2035	0316-2035-50	D	Discontinued by firm	2026-10-05
excluded package	package	0316-2035	0316-2035-60	D	Discontinued by firm	2026-10-05

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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0316-2035-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0316-2035-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0316-2035-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0316-2035-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0316-2035-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0316-2035-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0316-2035-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0316-2035-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0316-2035-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0316-2035-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0316-2035-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0316-2035-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0316-2035-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0316-2035-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0316-2035-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0316-2035-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0316-2035-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0316-2035-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0316-2035-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0316-2035-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0316-2035-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0316-2035-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0316-2035-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0316-2035-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0316-2035-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0316-2035-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0316-2035-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0316-2035-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0316-2035-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0316-2035-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0316-2035-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0316-2035-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0316-2035-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0316-2035-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0316-2035-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0316-2035-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0316-2035-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0316-2035-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0316-2035-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0316-2035-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0316-2035-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0316-2035-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0316-2035-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0316-2035-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0316-2035-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0316-2035-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0316-2035-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0316-2035-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0316-2035-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0316-2035-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0316-2035-50	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)	INACTIVE INGREDIENT	035JKJ76MT	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
ETHYLHEXYL STEARATE	INACTIVE INGREDIENT	EG3PA2K3K5	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)	INACTIVE INGREDIENT	AG75W62QYU	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
METHYL GLUCOSE DIOLEATE	INACTIVE INGREDIENT	FA9KFJ4Z6P	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
OCTYLDODECYL NEOPENTANOATE	INACTIVE INGREDIENT	X8725R883T	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
PEG-7 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	WE09129TH5	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
PROPANEDIOL	INACTIVE INGREDIENT	5965N8W85T	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)	INACTIVE INGREDIENT	25LXE464L2	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]	8

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
0316-2035-10	00316203510	5 mL in 1 PACKET (0316-2035-10)	5 ml	2004-04-01	0000-00-00	No	No	Current
0316-2035-30	00316203530	89 mL in 1 TUBE (0316-2035-30)	89 ml	2006-01-03	0000-00-00	No	No	Current
0316-2035-40	00316203540	148 mL in 1 BOTTLE, PLASTIC (0316-2035-40)	148 ml	2003-12-08	0000-00-00	No	No	Current
0316-2035-45	00316203545	148 mL in 1 TUBE (0316-2035-45)	148 ml	2019-01-02	0000-00-00	No	No	Current
0316-2035-50	00316203550	259 mL in 1 BOTTLE, PLASTIC (0316-2035-50)	259 ml	2005-01-03	0000-00-00	No	No	Current
0316-2035-60	00316203560	3785 mL in 1 JUG (0316-2035-60)	3785 ml	2004-02-02	0000-00-00	No	No	Current

Blue Lizard Baby

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#