FDA.reportPublic FDA data

H-E-B SOLUTIONS SUNSCREEN BABY SPF 50 LOTION

Manufacturer
H.E.B
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:25:45

Label at a glance#

ProductH.E.B BABY
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protetion measures (see  Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply:    • after 80 minutes of swimming or sweating    • immediately after towel drying    • at least every 2 hours children under 6 months of age: ask a doctor Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and o...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protetion measures (see  Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use • on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product • keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if • rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:

   • after 80 minutes of swimming or sweating

   • immediately after towel drying

   • at least every 2 hours

  • children under 6 months of age: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including:

   • limit time in the sun, especially from 10 a.m. - 2 p.m.

   • wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive Ingredient(s)

INACTIVE INGREDIENT SECTION

water, butyloctyl salicylate, butylene glycol, glyceryl stearate, microcrystalline cellulose, behenyl alcohol, butylated PVP, stearic acid, lauryl alcohol, myristyl alcohol, cetyl alcohol, caprylic/capric triglyceride, tocopherol, sodium ascorbyl phosphate, cellulose gum, disodium EDTA, benzoic acid, benzoic alcohol, sorbic acid.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-527-7731

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H-E-B SOLUTIONS SUNSCREEN BABY SPF 50 LOTION

8 FL OZ (237mL)

NDC 37808-913-12

LabelLabel

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-91337808-913-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DOCOSANOL9G1OE216XYIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MYRISTYL ALCOHOLV42034O9PUIACT
STEARIC ACID4ELV7Z65APIACT
SORBIC ACIDX045WJ989BIACT
LAURYL ALCOHOL178A96NLP2IACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
BENZOIC ACID8SKN0B0MIMIACT
TOCOPHEROLR0ZB2556P8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H.E.B BABYSPF 50 SUNSCREENH.E.B61273611-ab7a-4216-aebe-2c8d896602812024-10-15WarningsExact identifier
ndc (package): 37808-913-12
ndc (product): 37808-913
ndc11 (package): 37808091312
spl id: 2489deb6-247b-7026-e063-6394a90ab5eb
spl set id: 61273611-ab7a-4216-aebe-2c8d89660281

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.