FDA.reportPublic FDA data

Blue Lizard Baby SPF 50

Product NDC
0316-2011
11-digit product format
003162011
Labeler code
0316
Product ID
0316-2011_5eec5909-63f3-82d8-e063-6394a90aaa0d
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 Baby SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 mg/g

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 Baby SPF 50 Sunscreen Stick
2023-02-13Blue Lizard Baby SPF 50 Sunscreen Stick
2023-01-30Blue Lizard Baby SPF 50 Sunscreen Stick
2023-01-30Blue Lizard Baby SPF 50 Sunscreen Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2011-05Blue Lizard Baby SPF 501 in 1 BLISTER PACKSTICK18
0316-2011-05Blue Lizard Baby SPF 5014 g in 1 CYLINDERSTICK148

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2011BLUE LIZARD BABY SPF 50 (ZINC OXIDE) STICK [CROWN LABORATORIES]7Current NDC, Legacy NDC, 2 package rows20250519_9948f5b8-43bd-1c99-e053-2a95a90a6121.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 228 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2e5c2add-8ed0-a990-e063-6394a90a87ea2025-02-14WarningsExact identifier
application number: M020
Les Duets - Shield of Helios, sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f75a5-6a3b-a129-e063-6394a90a52a02025-02-14WarningsExact identifier
application number: M020
Le Mieux Naked Glow Bronzer SPF 50SUNSCREENYB CHEMIA LLC46465db7-c1f0-6980-e063-6294a90a3ed82025-02-14WarningsExact identifier
application number: M020
Sheer Tint Mineral SPF Serum - Light LightZINC OXIDEMineral Fusion brandsac6fdc35-82f8-4805-875e-2aa91aedec6f2025-02-14WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 50ZINC OXIDEPeer Pharm Ltd.3989eebc-7262-4cda-84a1-ca30b638b7722025-02-13WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 30ZINC OXIDEPeer Pharm Ltd.8ee9f97b-9081-4e0c-aa7a-27a31cbee17a2025-02-13WarningsExact identifier
application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Medium DeepZINC OXIDEPeer Pharm Ltd.45ed56e1-46cb-46de-b11a-e814a7446e572025-02-13WarningsExact identifier
application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Light MediumZINC OXIDEPeer Pharm Ltd.6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a2025-02-13WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe99311c2-ed8b-6e60-e053-2a95a90a9bc22025-02-13WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC525f7bae-44b8-44e4-93ea-32995eca25662025-02-13WarningsExact identifier
application number: M020
DreamBeam Sunscreen SunlitSUNSCREEN ZINC OXIDEKosas Cosmetics, LLC2e093b82-2a36-cc0f-e063-6394a90a4d6d2025-02-13WarningsExact identifier
application number: M020
DreamBeam SunscreenSUNSCREEN ZINC OXIDEKosas Cosmetics, LLCf93b0091-6a41-ae6e-e053-6394a90a86d72025-02-13WarningsExact identifier
application number: M020
Revealer Skin-Improving FoundationSUNSCREEN ZINC OXIDEKosas Cosmetics, LLC2e0a0cd6-c302-2017-e063-6394a90a60b82025-02-13WarningsExact identifier
application number: M020
Hi papa KIDS MINERAL FACE SUNSCREENSUNSCREENGUANG DONG 3 INS TECHNOLOGY Co., Ltd2deea723-32a0-da33-e063-6294a90accdd2025-02-12WarningsExact identifier
application number: M020
Quick Screen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Quick Flick PTY LTD3788666e-7efa-43da-95f5-6218b7fcb6ea2025-02-12WarningsExact identifier
application number: M020
Dolce AND Gabbana Get Your Healthy Glowy SkinZINC OXIDESocoplan91bf1cca-8d18-4c59-864d-4fd0619c67132025-02-12WarningsExact identifier
application number: M020
Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dfd1f99-5896-1e0f-e063-6394a90aa71d2025-02-12WarningsExact identifier
application number: M020
Biore Aqua Rich UVOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USAf9024581-dbab-b7cb-e053-6294a90a8b9a2025-02-12WarningsExact identifier
application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLCebdaf6c1-1572-4840-851b-6d780471fcb22025-02-11WarningsExact identifier
application number: M020
Sky and Sol Body Sunscreen SPF50SKY AND SOL BODY SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd2de9173b-fa02-8017-e063-6394a90ae0aa2025-02-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2011-05003162011051 CYLINDER in 1 BLISTER PACK (0316-2011-05) / 14 g in 1 CYLINDER1 cylinder2019-11-250000-00-00NoNoCurrent