FDA.reportPublic FDA data

H-E-B SOLUTIONS SUNSCREEN MANGO SPF 50 LOTION

Manufacturer
H.E.B
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:52:19

Label at a glance#

ProductH.E.B MANGO
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, glycerin, silica, aluminum starch octenylsuccinate, behenyl alcohol, phenoxyethanol, glyceryl stearate, arachidyl alcohol, ethylhexylglycerin, arachidyl glucoside, PEG-100 stearate, sodium ascorbyl phosphate, saccharomyces/podophyllum peltatum ferment filtrate, polyester-7, neopentyl glycol diheptanoate, styrene/acrylates copolymer, isododecane, tocopherol (vitamin E), beeswax, potassium hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, butylene glycol, fragrance

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-527-7731

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H-E-B SOLUTIONS SUNSCREEN MANGO SPF 50 LOTION

8 FL OZ (237mL)

NDC 37808-916-12

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-91637808-916-12

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
DOCOSANOL9G1OE216XYIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
PEG-100 STEARATEYD01N1999RIACT
TOCOPHEROLR0ZB2556P8IACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
ISODODECANEA8289P68Y2IACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
YELLOW WAX2ZA36H0S2VIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
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
b948911f-6e93-40e7-e053-2a95a90a02a876ce3c14-d4d5-4a55-9ba9-e476744b05a12024-10-15WarningsExact identifier
spl id: b948911f-6e93-40e7-e053-2a95a90a02a8
spl set id: 76ce3c14-d4d5-4a55-9ba9-e476744b05a1

Reported adverse events (FAERS/openFDA)#

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