FDA.reportPublic FDA data

Sunscreen for Babies SPF 50

Product NDC
11344-947
11-digit product format
113440947
Labeler code
11344
Product ID
11344-947_4ceb1800-c9d1-86f7-e063-6294a90a785a
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-06
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 120; 50 mg/mL; mg/mL; mg/mL
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
Sunscreen for Babies SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE120 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a4b9d7c0-dc09-4f0e-8b65-90ba180552bfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-947-34Sunscreen for Babies SPF 50236 mL in 1 BOTTLE, PLASTICLOTION2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-947SUNSCREEN FOR BABIES SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [CONSUMER PRODUCT PARTNERS, LLC]2Current NDC, 1 package rows20250510_a4b9d7c0-dc09-4f0e-8b65-90ba180552bf.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 194 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby, LLCafc88e77-a4a1-49ec-b021-bb468fd0ac682025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD31049b45-0f5e-58b6-e063-6394a90ae52c2025-08-12WarningsExact identifier
application number: M020
Earth Mama Lady Face Mineral Sunscreen - Light/Medium Tint Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby LLCbd71a814-c0b4-428b-987e-72f7f55f998f2025-08-12WarningsExact identifier
application number: M020
earth mama UBER-SENSITIVE MINERAL Sunscreen SPF 40ZINC OXIDEEarth Mama Angel Baby, LLCe9a88a57-5733-489d-a459-dd74c04daff22025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddae545-99db-144b-e063-6294a90adae52025-08-12WarningsExact identifier
application number: M020
Sun Bum Protecting Scalp and Hair Mist SPF 30 sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3aa05afb-c843-f38f-e063-6294a90a1cdf2025-08-12WarningsExact identifier
application number: M020
Sun Bum High Performance Sunscreen Signature Clear 50OCTOCRYLENE, OCTISALATE, ZINC OXIDESun Bum, LLC390c6afd-e2be-414c-e063-6294a90ae1192025-08-12WarningsExact identifier
application number: M020
Sun Bum 30 Premium Mosturizing Sunscreen 1 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c32d2c0-0dbe-42e3-e063-6294a90aa9932025-08-12WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c342e57-cf85-b423-e063-6394a90a61b92025-08-12WarningsExact identifier
application number: M020
MATTE UNIVERSAL TINTED MOISTURIZER SPF46ZINC OXIDE, OCTINOXATEDrmtlgy, LLC8e284afd-b90f-41d5-b334-e5cf4440b4d32025-08-12WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 22N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lad8afa83-2844-422c-b2bf-b5a61be368b12025-08-11WarningsExact identifier
application number: M020
ScarAid SPFSILICONE STICK WITH SPFBiodermis, LLC3c19063a-cdde-1bbe-e063-6294a90aa8a22025-08-11WarningsExact identifier
application number: M020
Pro-Sil SPFSILICONE STICK WITH SPFBiodermis, LLC3be06f82-935d-b1c2-e063-6294a90a953c2025-08-11WarningsExact identifier
application number: M020
Curology Daily MoisturizingAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECurology, Inc3c1967fc-bb89-2f7e-e063-6394a90a25122025-08-11WarningsExact identifier
application number: M020
ScarAid US SPFSILICONE STICK WITH SPFBiodermis, LLC3c196fa4-1bd3-7a43-e063-6294a90a4fb72025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 23W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L96973dee-681b-4c5d-b31f-de05cd79fa182025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 24N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lecda3658-eca1-48c2-9eff-e22fd1ff70df2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc6f27df4-6de4-45e4-90cb-ea8b0d29dbd32025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L968abacd-8b99-4529-a627-2b56cdf99e1b2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-947-3411344094734236 mL in 1 BOTTLE, PLASTIC (11344-947-34) 236 ml2024-05-06NoNoCurrent