FDA.reportPublic FDA data

SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREEN LOTION

Manufacturer
THE KROGER COMPANY
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:00

Label at a glance#

ProductSIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREEN
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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 other sun pro...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.0%, Zinc Oxide 15.0%

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, neopentyl glycol diheptanoate, caprylic/capric triglyceride, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, C30-38 olefin/isopropyl maleate/ MA copolymer, sorbitan tristearate, silica, stearyl/octyldodecyl citrate crosspolymer, VP/hexadecene copolymer, phenoxyethanol, magnesium sulfate, citric acid, glycerin, stearyl alcohol, glyceryl stearate, simmondsia chinensis (jojoba) seed oil, polysorbate 60, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, ethylhexylglycerin, aloe barbadensis leaf juice, avena sativa (oat) kernel extract, glycine soja (soybean) seed extract, tocopherol.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33235A233235A2

33236A233236A2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-819-12SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREEN236 mL in 1 TUBELOTION2363
30142-819-15SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREEN177 mL in 1 TUBELOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-819SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [THE KROGER COMPANY]3Current NDC, Legacy NDC, 2 package rows20231027_a52872bf-cd0f-06da-e053-2995a90af28d.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-81930142-819-15, 30142-819-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
OATZ6J799EAJKIACT
JOJOBA OIL724GKU717MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
SORBITAN TRISTEARATE6LUM696811IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
ALOE VERA LEAFZY81Z83H0XIACT
SOYBEANL7HT8F1ZODIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DOCOSANOL9G1OE216XYIACT
TOCOPHEROLR0ZB2556P8IACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL 1-STEARATE258491E1RZIACT
POLYSORBATE 60CAL22UVI4MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
ZINC OXIDESOI2LOH54ZACTIB
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML · Source PDF

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
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
ndc (package): 30142-819-15
ndc (package): 30142-819-12
ndc (product): 30142-819
ndc11 (package): 30142081915
ndc11 (package): 30142081912
spl id: 08a348a0-009f-4f33-e063-6394a90ad6ed
spl set id: a52872bf-cd0f-06da-e053-2995a90af28d