FDA.reportPublic FDA data

SPF30 SHEER TOUCH TINTED SUNSCREEN

Manufacturer
Andalou naturals
Effective date
2020-10-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:38:34

Label at a glance#

ProductSPF30 SHEER TOUCH TINTED SUNSCREEN LIGHT - MEDIUM
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

Helps prevent sunburn if used as directed with other sun protection measures (see Directions ) decreases the risk of early skin ageing caused by the sun.

Dosage and administration

Apply liberally 15minutes before sun exposure reapply: after swimming, sweating, immediately after towel drying every 2 hours Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk regularly use a sunscreen with broad spectrum protection value of SPF15 or higher and other sun protection measures including: Limit time in the sun, especially ...

Storage and handling

Protect this product from excessive heat and direct sun may stain some fabrics.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (21.5%)

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 early skin ageing caused by the sun.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin
  • Keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

  • Stop use and ask a doctor if a 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 centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15minutes before sun exposure

  • reapply:
    • after swimming, sweating,
    • immediately after towel drying
    • every 2 hours
  • Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk regularly use a sunscreen with broad spectrum protection value of SPF15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10am to 2pm
    • wear long sleeved shirts, pants, hat and sunglasses.
    • children under 6 months of age ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

  • may stain some fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Isoamyl Laurate, Caprylic/Capric Triglyceride, Sorbitan Stearate, Cetearyl Alcohol, Hydroxypropyl Starch Phosphate, Phenethyl Alcohol, Caprylyl Glycol, Glyceryl Isostearate, Xanthan Gum, Polyhydroxystearic Acid, Cetearyl Glucoside, Sucrose Cocoate, Rosa Canina Fruit Oil, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis Leaf Extract, Potassium Sorbate, Fragrance (Parfum), CI 77492, CI 77491, CI 77499.

Questions?

OTC - QUESTIONS SECTION

Call: AUS: 1300 858 898 CANADA: 1-888-464-6775

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - LIGHT - MEDIUM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sukin®
AUSTRALIAN • NATURAL

SUNCARE

• REEF SAFE •
REEF SAFE

SPF30

SHEER TOUCH
TINTED
SUNSCREEN

UVA & UVB
BROAD SPECTRUM

LIGHT - MEDIUM

NO OXYBENZONE

60mL/2.03 fl oz

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - LIGHT - MEDIUM
PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - LIGHT - MEDIUM

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - MEDIUM - DARK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sukin®
AUSTRALIAN • NATURAL

SUNCARE

• REEF SAFE •
REEF SAFE

SPF30

SHEER TOUCH
TINTED
SUNSCREEN

UVA & UVB
BROAD SPECTRUM

MEDIUM - DARK

NO OXYBENZONE

60mL/2.03 fl oz

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - MEDIUM - DARK
PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - MEDIUM - DARK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55560-5002-12025-01-30C16284748780-1f386c649-e296-0266-e053-dadaa90a7c1aSPF30 SHEER TOUCH TINTED SUNSCREEN
55560-5003-12025-01-30C16284748780-1f386c649-e296-0266-e053-dadaa90a7c1aSPF30 SHEER TOUCH TINTED SUNSCREEN
55560-5002-12023-01-31C16284748780-1f386c649-e296-0266-e053-dadaa90a7c1aSPF30 SHEER TOUCH TINTED SUNSCREEN
55560-5003-12023-01-31C16284748780-1f386c649-e296-0266-e053-dadaa90a7c1aSPF30 SHEER TOUCH TINTED SUNSCREEN
55560-5002-12023-01-30C16284748780-1f386c649-e296-0266-e053-dadaa90a7c1aSPF30 SHEER TOUCH TINTED SUNSCREEN
55560-5003-12023-01-30C16284748780-1f386c649-e296-0266-e053-dadaa90a7c1aSPF30 SHEER TOUCH TINTED SUNSCREEN

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55560-5002SPF30 SHEER TOUCH TINTED SUNSCREEN LIGHT - MEDIUM (ZINC OXIDE) LOTION SPF30 SHEER TOUCH TINTED SUNSCREEN MEDIUM - DARK (ZINC OXIDE) LOTION [ANDALOU NATURALS]3Legacy NDC20230202_aad1ac30-feb2-4434-b440-4cce8806d7b6.zip
55560-5003SPF30 SHEER TOUCH TINTED SUNSCREEN LIGHT - MEDIUM (ZINC OXIDE) LOTION SPF30 SHEER TOUCH TINTED SUNSCREEN MEDIUM - DARK (ZINC OXIDE) LOTION [ANDALOU NATURALS]3Legacy NDC20230202_aad1ac30-feb2-4434-b440-4cce8806d7b6.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55560-500255560-5002-1
55560-500355560-5003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ISOAMYL LAURATEM1SLX00M3MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
XANTHAN GUMTTV12P4NEEIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
SUCROSE COCOATE3H18P0UK73IACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SAFFLOWER OIL65UEH262ISIACT
GLYCERINPDC6A3C0OXIACT
CUCUMBERYY7C30VXJTIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ISOAMYL LAURATEM1SLX00M3MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
XANTHAN GUMTTV12P4NEEIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
SUCROSE COCOATE3H18P0UK73IACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SAFFLOWER OIL65UEH262ISIACT
GLYCERINPDC6A3C0OXIACT
CUCUMBERYY7C30VXJTIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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
a5ed3b14-13ff-4e99-996f-0ea3399da208aad1ac30-feb2-4434-b440-4cce8806d7b62026-03-12WarningsExact identifier
spl set id: aad1ac30-feb2-4434-b440-4cce8806d7b6

Reported adverse events (FAERS/openFDA)#

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