FDA.reportPublic FDA data

Blue Lizard Kids SPF 50

Product NDC
0316-2012
11-digit product format
003162012
Labeler code
0316
Product ID
0316-2012_5eeaed97-418b-b040-e063-6294a90af7e5
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Crown Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-25
Substance
ZINC OXIDE
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Kids SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
9983563c-1e63-0748-e053-2a95a90a971eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-13Blue Lizard Kids SPF 50 Sunscreen Stick
2023-02-13Blue Lizard Kids SPF 50 Sunscreen Stick
2023-01-30Blue Lizard Kids SPF 50 Sunscreen Stick
2023-01-30Blue Lizard Kids SPF 50 Sunscreen Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2012-05Blue Lizard Kids SPF 5014 g in 1 CYLINDERSTICK147
0316-2012-05Blue Lizard Kids SPF 501 in 1 BLISTER PACKSTICK17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2012BLUE LIZARD KIDS SPF 50 (ZINC OXIDE) STICK [CROWN LABORATORIES]6Current NDC, Legacy NDC, 2 package rows20250519_9983563c-1e63-0748-e053-2a95a90a971e.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 330 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2NENSULIZOLE, OCTISALATEParfums Christian Diorc790b9e4-6925-4796-9945-1c5484116a232023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2WENSULIZOLE, OCTISALATEParfums Christian Diorf551db8d-7447-41b9-9249-5ee8f76be98a2023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior775f4009-9fc2-475b-a141-b4b5e55421802023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior189f8767-f463-4c83-8a38-975ce8672b2a2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1,5NENSULIZOLE, OCTISALATEParfums Christian Diord9c6e0e0-f88e-48ba-94db-0cb198f8dbbe2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 3NENSULIZOLE, OCTISALATEParfums Christian Diora1e5e9cf-3f59-4e1d-98d6-f17ed1ad8e512023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2CRENSULIZOLE, OCTISALATEParfums Christian Dior2345d277-3d46-4dfc-9c5d-db7887165ea62023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 5NENSULIZOLE, OCTISALATEParfums Christian Diorcfd207af-d650-4333-a79a-c8f4878e8f9a2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 7NENSULIZOLE, OCTISALATEParfums Christian Dior5f5e61e3-ea93-401b-b55c-1eb0a711e7382023-11-03WarningsExact identifier
application number: M020
FOREVER SKIN VEIL Extreme Wear and Moisturizing Primer Correction, Protection, Illumination With Sunscreen Floral Extract-Enriched Broad Spectrum SPF20OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc59b4ece-0534-4072-afe8-2142a43c6bb22023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 4NENSULIZOLE, OCTISALATEParfums Christian Diorcfeb19b9-6597-4bd7-a635-d4024e291c5c2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 6NENSULIZOLE, OCTISALATEParfums Christian Diorc044849f-94ab-4d91-aac5-e3e9631bc8b12023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Diorcdc2a156-5ccd-4d40-98af-c529f0911a9e2023-11-03WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h Wear Radiant Perfection Skin Caring Foundation With Sunscreen BROAD SPECTRUM SPF 35 Lasting Hydration 2WPOCTINOXATE, TITANIUM DIOXIDEPARFUMS CHRISTIAN DIOR6ee0284e-739d-4aad-9352-9ea9c106efa42023-11-03WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Coconut Lip BalmZINC OXIDERaining Rose, Inc.2a03abc4-824b-438d-acc5-4698530576792023-11-03WarningsExact identifier
application number: M020
BEAUTY BEFORE AGE AHAVA UPLIFT DAY broad spectrum SPF 20HOMOSALATE, OCTISALATE, AND AVOBENZONEAHAVA Dead Sea Laboratories Ltdbf872bbe-a2d1-4188-b331-e62e339b13e72023-11-03WarningsExact identifier
application number: M020
All Good Broad Spectrum SPF 15 Spearmint Lip BalmBROAD SPECTRUM SPF 15 SPEARMINT LIP BALMRaining Rose, Inc.77370d4e-6888-4cb7-b6b9-1011a71dbf7a2023-11-03WarningsExact identifier
application number: M020
365 Everyday ValueSPORT LOTION MINERAL SUNSCREEN SPF 30Whole Foods Market, Inc.8f15b988-c009-4ca7-bb46-c0fb0aa626432023-11-03WarningsExact identifier
application number: M020
365 Everyday ValueSPORT LOTION MINERAL SUNSCREEN SPF 30Whole Foods Market, Inc.706ed90d-fd98-44bf-99b8-f8c12eec68572023-11-03WarningsExact identifier
application number: M020
THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC97787725-9175-46a7-8e3a-af5d06e21d7f2023-10-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2012-05003162012051 CYLINDER in 1 BLISTER PACK (0316-2012-05) / 14 g in 1 CYLINDER1 cylinder2019-11-250000-00-00NoNoCurrent