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 42 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.6a48ad0d-20e4-44b1-90d6-30bfbc68a1522026-04-17WarningsExact identifier
application number: M020
Pacto Refreshing Sunscreen Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEMynd LLC56ad7c97-3dae-4bac-a677-f5052dfdfea42026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f95cd0a-f996-648b-e063-6294a90adc282026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f968058-e851-86d0-e063-6294a90aa7862026-04-16WarningsExact identifier
application number: M020
Red Cherry SPF 15 Broad Spectrum Lip BalmRED CHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc4f96d057-39b8-e4d5-e063-6394a90acb5c2026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f970778-97d6-40a9-e063-6394a90a6c892026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-LightZINC OXIDEZO Skin Health, Inc.4f9988a0-ae4a-9940-e063-6294a90ad91d2026-04-16WarningsExact identifier
application number: M020
MELAO Hydrating Mineral SunscreenTITANIUM DIOXIDE,ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4f778eb0-55f7-38d0-e063-6394a90a69a02026-04-15WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC75820400-a5e0-4cf5-8b4f-a52500ce62c32026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f81e482-8111-451c-e063-6294a90ad1482026-04-15WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f8353b3-4ac1-9703-e063-6294a90abdad2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f83dd76-a8d8-916e-e063-6294a90ab6ed2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick - TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f84619f-3415-7443-e063-6394a90a162a2026-04-15WarningsExact identifier
application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDEPML NYC, LLC1be639a8-179a-7015-e063-6394a90ab64b2026-04-15WarningsExact identifier
application number: M020
PHELITYL DAY SPF 15PHELITYL DAY SPF 15PML NYC, LLCea9d33d9-6f9f-0a66-e053-2a95a90abd422026-04-15WarningsExact identifier
application number: M020
FIRMARINE MOISTURIZER SPF 30FIRMARINE MOISTURIZER SPF 30PML NYC, LLCea9db179-1b69-01e0-e053-2a95a90a16282026-04-15WarningsExact identifier
application number: M020
EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15PML NYC, LLCeaa562b1-3fc6-1a85-e053-2995a90ad1ec2026-04-15WarningsExact identifier
application number: M020
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30PML NYC, LLCea90bb4d-6f4a-45c9-e053-2a95a90a53a72026-04-15WarningsExact identifier
application number: M020
RICH GIRL HAND SPF 25RICH GIRL HANDPML NYC, LLCea8f4421-109f-41a5-e053-2a95a90a38322026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTERYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e24a63e-d76f-6581-e063-6394a90a61812026-04-15WarningsExact 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