FDA.reportPublic FDA data

H-E-B SOLUTIONS SUNSCREEN ULTRA SPF 30 CONTINUOUS SPRAY

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 00:25:47

Label at a glance#

ProductH.E.B ULTRA
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure14 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 hold can 4-6 inches away from body, spray evenly to ensure complete coverage do not spray into face. Spray into hand and apply to face. use in well ventilated, but not windy areas 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%

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

FLAMMABLE:

WARNINGS AND PRECAUTIONS SECTION

  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)

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
  • hold can 4-6 inches away from body, spray evenly to ensure complete coverage
  • do not spray into face. Spray into hand and apply to face.
  • use in well ventilated, but not windy areas
  • 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

SD alcohol 40-B, butyloctyl salicylate, acrylates/octylacrylamide copolymer, glycerin, caprylic/capric triglyceride, stearoxytrimethylsilane, tocopherol, butylene glycol, panthenol, saccharomyces/podophyllum peltatum ferment filtrate

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-527-7731

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H-E-B SOLUTIONS SUNSCREEN ULTRA SPF 30 CONTINUOUS SPRAY

5.5 OZ (156g)

NDC 37808-923-37

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-924-37H.E.B ULTRA156 g in 1 CANAEROSOL, SPRAY1562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-924H.E.B ULTRA (SPF 30 SUNSCREEN) AEROSOL, SPRAY [H.E.B]2Current NDC, Legacy NDC, 1 package rows20241017_90287874-cdfa-489c-936d-e487f6b3db96.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-92437808-924-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
PANTHENOLWV9CM0O67ZIACT
TOCOPHEROLR0ZB2556P8IACT
STEAROXYTRIMETHYLSILANE9862TW94B2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
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 ULTRASPF 30 SUNSCREENH.E.B90287874-cdfa-489c-936d-e487f6b3db962024-10-15WarningsExact identifier
ndc (package): 37808-924-37
ndc (product): 37808-924
ndc11 (package): 37808092437
spl id: c71836b9-92d1-6659-e053-2a95a90aa3a5
spl set id: 90287874-cdfa-489c-936d-e487f6b3db96

Reported adverse events (FAERS/openFDA)#

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