FDA.reportPublic FDA data

SunClear

Manufacturer
Grahams Natural Alternatives Pty Ltd
Effective date
2015-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:29

Label at a glance#

ProductSunClear
Active ingredientZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Zinc Oxide 25%

OTC - PURPOSE SECTION

Purpose

sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a poison control center immediately.

INDICATIONS & USAGE SECTION

Uses

helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Directions

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: ask a doctor

WARNINGS SECTION

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

DESCRIPTION SECTION

Reef Friendly

Non Nano

SunClear SPF 30 sunscreen

UVA & UVB

Broad Spectrum Protection

Very Water Resistant

80 minutes

Sensitive Skin Formula

Thank you for choosing our premium eco friendly Sunscreen.

It is tried and tested under the harsh conditions of the Australian sun! Especially formulated for those with sensitive skin and all skin types.

SunClear Natural sunscreen is the perfect sunblock that will not harm you, the water, the earth or the coral reefs!

OTC - QUESTIONS SECTION

Other Information

protect this product from excessive heat and direct sun

Questions  www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Court, Nerang, QLD 4211 Australia

INACTIVE INGREDIENT SECTION

Inactive Ingredients

caprylic/capric trilglyceride, rosa canina seed (rose hip) oil, vitis vinifera seed (grape seed) oil, olea europaea (extra virgin olive) oil, sesamum indicum (sesame) oil, butyspermum parkii (shea) butter, tocopherol (natural vitamin E), provitamin A, phenoxyethanol, coconut oil.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42387-001-012020-01-31C16284748780-19d75b9cf-f5cc-f424-e053-dadaa90a57ce6dc568bf-88b7-42e1-bdd0-835ec65aaa9a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42387-001-01SunClear150 g in 1 PACKAGECREAM1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42387-001SUNCLEAR (ZINC OXIDE) CREAM [GRAHAMS NATURAL ALTERNATIVES PTY LTD]1Legacy NDC, 1 package rows20150903_6dc568bf-88b7-42e1-bdd0-835ec65aaa9a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC CATIONACTIVE MOIETY13S1S8SF371
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEINACTIVE INGREDIENTFJ1H6M2JG91
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
ROSA CANINA SEEDINACTIVE INGREDIENT4503R1M9UT1
SESAME OILINACTIVE INGREDIENTQX10HYY4QV1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
VITAMIN AINACTIVE INGREDIENT81G40H8B0T1
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXA1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42387-00142387-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
ROSA CANINA SEED4503R1M9UTIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
OLIVE OIL6UYK2W1W1EIACT
SESAME OILQX10HYY4QVIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
VITAMIN A81G40H8B0TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
COCONUT OILQ9L0O73W7LIACT

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 · 25 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact identifier — unii candidate
2 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 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
be2d3046-d640-4da9-9cba-2df7d4b7f0e86dc568bf-88b7-42e1-bdd0-835ec65aaa9a2015-08-26WarningsExact identifier
spl id: be2d3046-d640-4da9-9cba-2df7d4b7f0e8
spl set id: 6dc568bf-88b7-42e1-bdd0-835ec65aaa9a

Reported adverse events (FAERS/openFDA)#

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