FDA.reportPublic FDA data

HEB SPF 55 Babies and Kids Sunscreen

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 00:25:59

Label at a glance#

ProductHEB SPF 55 Babies and Kids Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure12 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection 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 value of 15 or higher and othe...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on damaged or broken skin.

When using this product 

OTC - WHEN USING SECTION

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

• rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 value 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-sleeved shirts, pants, hats, and sunglasses

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredient(s)

INACTIVE INGREDIENT SECTION

beeswax, ozokertie, cetearyl behenate, lauryl lactate, polybutene, butyloctyl salicylate, cetyl alcohol, myristyl myristate, styrene/acrylates copolymer, theobroma cacao (cocoa) seed butter, phenoxyethanol, tetrahexyldecyl ascorbate (vitamin C ester), tocopherol (vitamin E).

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEB73324E1F1HEB73324E1F1

HEB20090E1FHEB20090E1F

HEB20090K1HEB20090K1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-908-01HEB SPF 55 Babies and Kids Sunscreen13.3 g in 1 CONTAINERSTICK13.32
37808-908-28HEB SPF 55 Babies and Kids Sunscreen42 g in 1 CONTAINERSTICK422

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-908HEB SPF 55 BABIES AND KIDS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [H.E.B.]2Current NDC, 2 package rows20241017_f5660a97-57c8-61c7-e053-2995a90a0164.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-90837808-908-28, 37808-908-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHITE WAX7G1J5DA97FIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETYL ALCOHOL936JST6JCNIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
COCOA BUTTER512OYT1CRRIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CERESINQ1LS2UJO3AIACT
STEARYL BEHENATEA68S9UI39DIACT
LAURYL LACTATEG5SU0BFK7OIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
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
HEB SPF 55 Babies and Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.f5660a97-57c8-61c7-e053-2995a90a01642024-10-15WarningsExact identifier
ndc (package): 37808-908-28
ndc (package): 37808-908-01
ndc (product): 37808-908
ndc11 (package): 37808090828
ndc11 (package): 37808090801
spl id: 2489b22e-7d08-8fdb-e063-6394a90acdb4
spl set id: f5660a97-57c8-61c7-e053-2995a90a0164

Reported adverse events (FAERS/openFDA)#

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