FDA.reportPublic FDA data

H.E.B BABY

Product NDC
37808-913
11-digit product format
378080913
Labeler code
37808
Product ID
37808-913_2489deb6-247b-7026-e063-6394a90ab5eb
Type
HUMAN OTC DRUG
Nonproprietary name
SPF 50 Sunscreen
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
H.E.B
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-05
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 45; 80 mg/mL; 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
H.E.B BABY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE45 mg/mL
OCTOCRYLENE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
61273611-ab7a-4216-aebe-2c8d89660281Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-913-12H.E.B BABY237 mL in 1 TUBEAEROSOL, SPRAY2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-913H.E.B BABY (SPF 50 SUNSCREEN) AEROSOL, SPRAY [H.E.B]2Current NDC, Legacy NDC, 1 package rows20241017_61273611-ab7a-4216-aebe-2c8d89660281.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 233 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zealios SPF LipGuardOCTISALATE AND AVOBENZONEPersonal Best Products Inc. dba Zealios3a07822b-a7c9-40af-a8f7-bea591c7a49b2025-01-13WarningsExact identifier
application number: M020
SPF-30 BBZINC OXIDEZION HEALTH66d33d8c-8900-4698-98fe-0dedafe674d82025-01-13WarningsExact identifier
application number: M020
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Incb2addf27-9139-48b4-85e6-618f4b5311cc2025-01-13WarningsExact identifier
application number: M020
Skin Apeel Ageless Defense SPF 40 Broad SpectrumZINC OXIDESkin Apeel, Inc.c3bbe779-b012-4f19-8b90-2c7a4dd886172025-01-13WarningsExact identifier
application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEKATE SOMERVILLE SKINCARE LLC1a33cb41-440a-41cb-9832-24255bfa2b7c2025-01-12WarningsExact identifier
application number: M020
ALLSWELL MINERAL SUNSCREEN SPF 30ZINC OXIDEStream2Sea, LLC03bee988-d6e3-4290-a926-9c5366649cba2025-01-12WarningsExact identifier
application number: M020
Baby Donna SHeer SPF Sunscreen StickZINC OXIDEStream2Sea, LLCa1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe2025-01-12WarningsExact identifier
application number: M020
SUN PROTECT LIP BALM SPF 30ZINC OXIDE AND TITANIUM DIOXIDEStream2Sea, LLC21386652-b952-48be-b077-1acecc7f0eb02025-01-12WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b5aebed-49f6-7bb8-e063-6294a90a85212025-01-10WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Drops Face SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b5c69e4-2819-94ef-e063-6394a90a68e72025-01-10WarningsExact identifier
application number: M020
Dermaroller Anhydrous Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.04e82f1b-c893-4795-b7a9-0523e3ec75522025-01-10WarningsExact identifier
application number: M020
Skinfuse Shield SPF 30ZINC OXIDEOwen Biosciences, Inc.b8e4c11a-4b4f-4e36-a75e-0a73913113d52025-01-10WarningsExact identifier
application number: M020
Correct and Protect Serum Broad Spectrum SPF 45ZINC OXIDEMurad, LLC60c62108-6806-4722-a44b-f1c300d59c1e2025-01-10WarningsExact identifier
application number: M020
Multi Vitamin Clear Coat Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLCe023c874-c89d-4bd0-a0b9-a8161c2614572025-01-10WarningsExact identifier
application number: M020
CoTZ BabyZINC OXIDEFallien Cosmeceuticals, LTD17cc12c7-5af8-413f-b205-31ac150583e22025-01-09WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.2b3bdbe1-ede9-cd60-e063-6394a90ab2f32025-01-09WarningsExact identifier
application number: M020
JAFRA ROYAL REVITALIZE 4 TUBE SETAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca982025-01-09WarningsExact identifier
application number: M020
glo SKIN BEAUTY Moisturizing Tint SPF 30GLO SKIN BEAUTY MOISTURIZING TINT SPF 30Hayden Caleel LLC2b464a70-8f40-3148-e063-6394a90ac18c2025-01-09WarningsExact identifier
application number: M020
Sunscreen and insect repellent Bull frogSPF 50Bullfrog Brands, LLCd65d15a6-0a32-1203-e053-2995a90aa6c52025-01-09WarningsExact identifier
application number: M020
Sunscreen and insect repellent Bull frogSPF 50Bullfrog Brands, LLCd5fb3632-24da-2c7a-e053-2a95a90a50812025-01-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-913-1237808091312237 mL in 1 TUBE (37808-913-12) 237 ml2019-02-050000-00-00NoNoCurrent