Blue Lizard Baby

Product NDC
0316-2035
Requested package NDC
0316-2035-10
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0316-20350316-2035-10DDiscontinued by firm2026-10-05

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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)INACTIVE INGREDIENT035JKJ76MTBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
ETHYLHEXYL STEARATEINACTIVE INGREDIENTEG3PA2K3K5BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)INACTIVE INGREDIENTAG75W62QYUBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTFA9KFJ4Z6PBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883TBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
PEG-7 HYDROGENATED CASTOR OILINACTIVE INGREDIENTWE09129TH5BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)INACTIVE INGREDIENT25LXE464L2BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
WATERINACTIVE INGREDIENT059QF0KO0RBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VBLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2035-10003162035105 mL in 1 PACKET (0316-2035-10) 5 ml2004-04-010000-00-00NoNoCurrent