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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0316-20450316-2045-30DDiscontinued by firm2026-10-16
excluded packagepackage0316-20450316-2045-45DDiscontinued by firm2026-10-16
excluded packagepackage0316-20450316-2045-50DDiscontinued by firm2026-10-16
excluded packagepackage0316-20450316-2045-60DDiscontinued by firm2026-10-16

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 datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050316-2045-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050316-2045-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050316-2045-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050316-2045-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260316-2045-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260316-2045-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260316-2045-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260316-2045-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310316-2045-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310316-2045-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310316-2045-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280316-2045-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280316-2045-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280316-2045-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210316-2045-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210316-2045-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210316-2045-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100316-2045-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100316-2045-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100316-2045-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310316-2045-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310316-2045-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310316-2045-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200316-2045-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200316-2045-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200316-2045-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100316-2045-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100316-2045-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100316-2045-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080316-2045-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080316-2045-45ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030316-2045-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030316-2045-45367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090316-2045-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090316-2045-45557ba5c1ecfa…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
IngredientStrength
TITANIUM DIOXIDE54 mg/mL
ZINC OXIDE108 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e4d49f4-9e77-48b5-bce5-ff04ed885a0fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2045-10Blue Lizard Sensitive Sunscreen5 mL in 1 PACKETLOTION519
0316-2045-30Blue Lizard Sensitive Sunscreen89 mL in 1 TUBELOTION8919
0316-2045-40Blue Lizard Sensitive Sunscreen148 mL in 1 BOTTLE, PLASTICLOTION14819
0316-2045-45Blue Lizard Sensitive Sunscreen148 mL in 1 TUBELOTION14819
0316-2045-50Blue Lizard Sensitive Sunscreen259 mL in 1 BOTTLE, PLASTICLOTION25919
0316-2045-60Blue Lizard Sensitive Sunscreen3785 mL in 1 JUGLOTION378519

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2045BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]17Current NDC, Legacy NDC, 6 package rows20241127_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 55 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CENTELLA SUNSCREEN CreamZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd4cbac4e9-7540-f703-e063-6394a90ad8082026-03-11WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.4ba8ed52-2f52-40b9-a810-8450f9b907782026-03-10WarningsExact identifier
application number: M020
COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-FreeZINC OXIDECOOLA LLC4cad89a5-325c-b3c2-e063-6294a90ac2252026-03-10WarningsExact identifier
application number: M020
Olay Complete plus Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 SensitiveAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4caf2ab5-76cb-4b0f-e063-6294a90a233e2026-03-10WarningsExact identifier
application number: M020
EWC Slow Lightweight Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEEWC Ventures, LLC063426b8-d1cf-4ee2-8ab8-ff007227eab82026-03-10WarningsExact identifier
application number: M020
Olay Vitamin C Brightening Facial Moisturizer with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4cb268ea-f2b5-ddd1-e063-6394a90a1e962026-03-10WarningsExact identifier
application number: M020
Vacation Grand Cuvee Shimmer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.e0b3d90b-ba56-43e5-aa68-8e5f473628ff2026-03-09WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique ANTHELIOS UVPRO SPORT INVISIBLE SUNSCREEN BROAD SPECTRUM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA, Inc.77f46325-600c-40ff-94fc-ea82d43134c22026-03-09WarningsExact identifier
application number: M020
Civant 50 Sunscreen Broad Spectrum SPF 50OCTOCRYLENE, ZINC OXIDECivant LLCe23622b8-49dd-45b9-8c51-1a83181cc7bd2026-03-09WarningsExact identifier
application number: M020
HydroScreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMETHODIQ INC.4c9d5dfd-d790-fffc-e063-6294a90a4d302026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 45 SunscreenZINC OXIDEShimoda Prime Products, LLC3d48e3e2-18c7-e004-e063-6294a90af4f22026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 30 SunscreenZINC OXIDEShimoda Prime Products, LLC68df620b-7c1c-448c-93fd-91459e393c642026-03-09WarningsExact identifier
application number: M020
EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEADEM, Inc.4ca05e2f-f0c5-821c-e063-6294a90a90b82026-03-09WarningsExact identifier
application number: M020
COOLA SunBlur Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c6439e8-abda-663a-e063-6394a90ac43b2026-03-06WarningsExact identifier
application number: M020
COOLA SunBlur Makeup Mist SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c666a82-293e-06df-e063-6294a90ad5512026-03-06WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4d6d1fda-da78-62ed-e063-6294a90ac1052026-03-06WarningsExact identifier
application number: M020
Palio Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESole Palio LLC071d5113-8fe8-44bb-8322-542eafc2800a2026-03-05WarningsExact identifier
application number: M020
Olay Age Defying Classic Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company4c49dbf1-d1fe-ad4a-e063-6394a90af1512026-03-05WarningsExact identifier
application number: M020
SPF 70 Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aadc378-dc34-9a37-e063-6294a90ad49e2026-03-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2045-10003162045105 mL in 1 PACKET (0316-2045-10) 5 ml2004-04-010000-00-00NoNoCurrent
0316-2045-300031620453089 mL in 1 TUBE (0316-2045-30) 89 ml2006-01-030000-00-00NoNoCurrent
0316-2045-4000316204540148 mL in 1 BOTTLE, PLASTIC (0316-2045-40) 148 ml2003-12-080000-00-00NoNoCurrent
0316-2045-4500316204545148 mL in 1 TUBE (0316-2045-45) 148 ml2019-01-020000-00-00NoNoCurrent
0316-2045-5000316204550259 mL in 1 BOTTLE, PLASTIC (0316-2045-50) 259 ml2005-01-030000-00-00NoNoCurrent
0316-2045-60003162045603785 mL in 1 JUG (0316-2045-60) 3785 ml2004-02-020000-00-00NoNoCurrent