FDA.reportPublic FDA data

SKIN STRONG SKIN EQUIPMENT - SPF 30 SUNSCREEN LOTION - DRUG FACTS LABEL

Manufacturer
True Balance Athletics LLC | Dhaliwal Labs
Effective date
2012-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:34:04

Label at a glance#

ProductSKIN STRONG - SKIN EQUIPMENT SPF 30 SUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure10 sections

Indications and uses

HELPS PREVENT SUNBURN HIGHER SPF GIVES MORE SUNBURN PROTECTION

Dosage and administration

APPLY LIBERALLY 20 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED FOR CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3.00%, HOMOSALATE 7.5%, OCTISALATE 5.00%, OCTOCRYLENE 2.75%, OXYBENZONE 4.00%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • HELPS PREVENT SUNBURN
  • HIGHER SPF GIVES MORE SUNBURN PROTECTION

WARNINGS:

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT:

  • KEEP OUT OF THE EYES
  • RINSE WITH WATER TO REMOVE

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS OR LASTS

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • APPLY LIBERALLY 20 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED
  • FOR CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR

SUN ALERT

OTHER SAFETY INFORMATION

LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING AND USING SUNSCREEN REDUCES THE RISK OF AGING, SKIN CANCER AND OTHER HARMFUL EFFECTS OF THE SUN.

INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, ADIPIC ACID/ DIETHYLENE DIGLYCOL GLYCERIN CROSSPOLYMER, C 12-15 ALKYL BENZOATE, ALOE BARBADENSIS LEAF EXTRACT, RETINYL PALMITATE, TOCOPHERYL ACETATE SODIUM ASCORBYL PHOSPHATE, STEARETH-21, TRIETHANOLAMINE, PROPYLENE GLYCOL, DECYL GLUCOSIDE, SORBITAN STEARATE, STEARETH-2, ACRYLATES/ C 10-30 ALKYL ACETATE CROSSPOLYMER, DIAZOLIDINYL UREA, METHYLPARABEN, CARBOMER, HYDROXYPROPYL, METHYLCELLULOSE, DISODIUM EDTA, PROPYLPARABEN

IMAGE OF LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF30LotionLabel.jpgIMAGE OF LABELIMAGE OF LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51401-030-012020-01-31C16284748780-19d75b9d0-67b4-f424-e053-dadaa90a57ceSKIN STRONG SKIN EQUIPMENT - SPF 30 SUNSCREEN LOTION - DRUG FACTS LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51401-030-01SKIN STRONG - SKIN EQUIPMENTSPF 30 SUNSCREEN118 mL in 1 BOTTLE, PUMPLOTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51401-030SKIN STRONG - SKIN EQUIPMENT SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [TRUE BALANCE ATHLETICS LLC ]2Legacy NDC, 1 package rows20121222_683d6fd0-ea36-4fdf-932c-8c44bf80ab2d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
HOMOSALATEACTIVE INGREDIENTV06SV4M95S2
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
HOMOSALATEACTIVE MOIETYV06SV4M95S2
OCTISALATEACTIVE MOIETY4X49Y0596W2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
OXYBENZONEACTIVE MOIETY95OOS7VE0Y2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DR2
STEARETH-21INACTIVE INGREDIENT53J3F32P582
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
51401-03051401-030-01

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
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALOE VERA LEAFZY81Z83H0XIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
STEARETH-2153J3F32P58IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58CREAM / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58LOTION / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates

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
e3470bcf-caa8-443f-91d5-329acba12c76683d6fd0-ea36-4fdf-932c-8c44bf80ab2d2012-12-19WarningsExact identifier
spl id: e3470bcf-caa8-443f-91d5-329acba12c76
spl set id: 683d6fd0-ea36-4fdf-932c-8c44bf80ab2d

Reported adverse events (FAERS/openFDA)#

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