FDA.reportPublic FDA data

Blue Lizard Baby SPF 50 Sunscreen

Product NDC
0316-2036
Requested package NDC
0316-2036-31
11-digit product format
003162036
Labeler code
0316
Product ID
0316-2036_4833f8fa-f0bc-dd53-e063-6294a90a3899
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
2020-01-29
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
89.6; 112 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Blue Lizard Baby SPF 50 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE89.6 mg/mL
ZINC OXIDE112 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
9d237fb7-4f5f-521d-e053-2a95a90a9734Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0316-2036-102023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-01-30Blue Lizard Baby SPF 50 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2036-10Blue Lizard Baby SPF 50 Sunscreen5 mL in 1 PACKETLOTION57
0316-2036-30Blue Lizard Baby SPF 50 Sunscreen89 mL in 1 TUBELOTION897
0316-2036-40Blue Lizard Baby SPF 50 Sunscreen148 mL in 1 BOTTLE, PLASTICLOTION1487
0316-2036-45Blue Lizard Baby SPF 50 Sunscreen148 mL in 1 TUBELOTION1487
0316-2036-46Blue Lizard Baby SPF 50 Sunscreen148 mL in 1 TUBELOTION1487
0316-2036-50Blue Lizard Baby SPF 50 Sunscreen259 mL in 1 BOTTLE, PLASTICLOTION2597
0316-2036-31Blue Lizard Baby SPF 50 Sunscreen89 mL in 1 TUBELOTION893
0316-2036-47Blue Lizard Baby SPF 50 Sunscreen148 mL in 1 TUBELOTION1483
0316-2036-55Blue Lizard Baby SPF 50 Sunscreen5 mL in 1 PACKETLOTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-2036-30ML - Milliliter0316-20363655f5e4-0f0e-451b-a621-1abaa50fae2912026-04-20
0316-2036-46ML - Milliliter0316-2036d84f5630-7517-4839-bf99-d83e7071f0c112026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2036BLUE LIZARD BABY SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]5Current NDC, Legacy NDC, 6 package rows20241127_9d237fb7-4f5f-521d-e053-2a95a90a9734.zip
0316-2036BLUE LIZARD BABY SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]2Current NDC, Legacy NDC, 3 package rows20250525_32d6e04a-fa30-ba48-e063-6394a90a1bbf.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 361 · 7,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d3d390-8b88-a6fe-e063-6394a90a9bf82026-08-12WarningsExact identifier
application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d7a3e3-b7df-43ce-e063-6294a90a729c2026-08-12WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-12WarningsExact identifier
application number: M020
doTERRA Sun BodyMINERAL SUNSCREENdoTERRA International, LLC58dcc56f-f093-469c-e063-6394a90a60882026-08-12WarningsExact identifier
application number: M020
Colorescience Total Protection Body Shield GlowZINC OXIDEColorescience52e1d987-a4f8-195e-e063-6294a90a56292026-08-11WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
application number: M020
Ciele Tint and ProtectZINC OXIDECiele0162d9c9-07fa-9210-e063-6294a90aa6872026-08-11WarningsExact identifier
application number: M020
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-08-10WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-10WarningsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.1c7cd904-ffff-48aa-91bd-cc978946b36a2026-08-10Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral Body ShieldZINC OXIDEColorescience52e1f59e-63cb-7480-e063-6394a90ad7c52026-08-10WarningsExact identifier
application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 SunscreenBEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDEGrace and Fire USA Inc.56ad0dce-410e-9d78-e063-6294a90a1c3e2026-08-09WarningsExact identifier
application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex SunscreenETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangzhou Yapheon Health Industry Co., Ltd.552a36ed-7a66-4048-e063-6394a90a09bc2026-08-08WarningsExact identifier
application number: M020
lip balm SPF15( 2533) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5870aa44-1375-cdc5-e063-6394a90af4a52026-08-07WarningsExact identifier
application number: M020
lip balm SPF15( Zinc oxide) 01ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.5871ab1d-cf07-d737-e063-6394a90a58fe2026-08-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0316-2036-310031620363189 mL in 1 TUBE (0316-2036-31) 89 ml2024-12-02NoNoCurrent