FDA.reportPublic FDA data

Sunscreen

Manufacturer
HEB | Consumer Product Partners, LLC
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 20:51:31

Label at a glance#

ProductSunscreen
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure15 sections

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minures of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.  To derease this risk,  reqularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in th...

Label contents#

Full prescribing information#

claims

SPL UNCLASSIFIED SECTION

H-E-B

Solutions

sunscreen

  • With Aloe and Vitamin E
  • Water Resistant (80 minutes)
  • Oil Free & Wont Clog Pores
  • Clear Zinc Sunscreen for Race, Nose or Ears

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octisalate 5%

Zinc oxide 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), mdecreases 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 - STOP USE 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 minures of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.  To derease this risk,  reqularly 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
  • children under 6 months of age: Ask a doctor

other information

OTHER SAFETY INFORMATION

  • protect the product from excessive heat and direct sun

inactive ingredients

INACTIVE INGREDIENT SECTION

water, butyloctyl salicylate, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, propanediol, triacontanyl PVP, cetearyl alcohol, PEG-100 stearate, cetearyl glucoside, glyceryl behenate, dimethicone, glycerin, PEG-150/decyl alcohol/SMDI copolymer, Aloe barbadensis leaf juice, allantoin, panthenol, tocopheryl acetate, triethoxycaprylylsilane, fragrance, phenoxyethanol, methylisothiazolinone, tetrasodium EDTA

Questions?

OTC - QUESTIONS SECTION

1-800-527-7731

Disclaimer

ADVERSE REACTIONS SECTION

May stain or damage some fabrics or surfaces

MADE WITH PRIDE AND CARE FOR H-E-B

SAN ANTONIO, TN 78204

MADE IN USA WITH U.S AND FOREIGN PARTS

100% GUARANTEE

Promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money.  You have our word on it

Principal panel display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H-E-B

Solutions

Sunscreen

CLEAR

ZINC

WITH OCTINOXATE & OCTISALATE

SUNSCREEN

BROAD SPECTRUM SPF 50

SPF 50

FOR FACE, NOSE OR EARS

  • With Aloe and Vitamin E
  • Water Resistant (80 minutes
  • Oil free & Wont Clog Pores

NET WT.

1 OZ (28.3 g)

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-726SUNSCREEN (OCTINOXATE, OCTISALATE, ZINC OXIDE) GEL [HEB]16Legacy NDC20241024_858ac80c-a0e5-4f0a-aa9f-62698fb29f58.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-72637808-726-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PROPANEDIOL5965N8W85TIACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEG-100 STEARATEYD01N1999RIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
PEG-150/DECYL ALCOHOL/SMDI COPOLYMER (1350 MPA.S AT 3%)VP5LS3541FIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALLANTOIN344S277G0ZIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
EDETATE SODIUMMP1J8420LUIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
3970c44e-4b07-ee85-e063-6394a90a55d9858ac80c-a0e5-4f0a-aa9f-62698fb29f582025-07-08Warnings, Adverse reactionsExact identifier
spl set id: 858ac80c-a0e5-4f0a-aa9f-62698fb29f58

Reported adverse events (FAERS/openFDA)#

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