FDA.reportPublic FDA data

Sunny Skin Glow Filter SPF50

Manufacturer
MCDONALD MULTINATIONAL PTY LTD
Effective date
2022-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:14

Label at a glance#

ProductSunny Skin Glow Filter SPF50
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Help Prevent Sunburn. If uses as directed with other sun protection measures (see directions ) decreases the risk of skin cancer and early ageing caused by the sun

Dosage and administration

For sunscreen use : • apply liberally 15 mins before sun exposure • apply to all skin exposed to the sun • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours. Children under 6 months old of age : ask 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 S...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22.75%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Help Prevent Sunburn. If uses as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early ageing caused by the sun

Warnings

WARNINGS SECTION

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 doctor is rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use: • apply liberally 15 mins before sun exposure • apply to all skin exposed to the sun • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours.
Children under 6 months old of age: ask 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 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

MediumChain(Caprylic/capric) triglycerides, Castor (Ricinus communis) Seed Oil, Coco-octanoate (Coco-caprylate/caprate), Coconut (Cocos nucifera) Oil, Candellila wax, Hydrogenated castor oil, polyglyceryl-3 polyricinoleate, Tocopheryl acetate, Iron oxides, isostearic acid, IBR-TCLC in Jojoba Oil 0705 (Simmondsia Chinensis (Jojoba) Seed Oil (and) Squalane (and) Solanum Lycopersicum (Tomato) Fruit Extract).

Other information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun.

Questions or Comments?
Email hello@sunnyskin.com

Product label

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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83070-002-012024-01-30C16284748780-11030e365-6a94-111a-e063-dadaa90a10e28f338854-1bcf-4dc4-8da2-46c3033fa042

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83070-002-01Sunny Skin Glow Filter SPF5050 mL in 1 TUBECREAM502
83070-002-01Sunny Skin Glow Filter SPF501 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83070-002SUNNY SKIN GLOW FILTER SPF50 (ZINC OXIDE) CREAM [MCDONALD MULTINATIONAL PTY LTD]2Legacy NDC, 2 package rows20221029_8f338854-1bcf-4dc4-8da2-46c3033fa042.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83070-00283070-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CASTOR OILD5340Y2I9GIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
CANDELILLA WAXWL0328HX19IACT
COCONUT OILQ9L0O73W7LIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ISOSTEARIC ACIDX33R8U0062IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
JOJOBA OIL724GKU717MIACT
SOLANUM LYCOCARPUM FRUITGL29VWX729IACT
SQUALANEGW89575KF9IACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIM

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
ec0a8e4e-cfd4-4aec-e053-2995a90a23c58f338854-1bcf-4dc4-8da2-46c3033fa0422022-10-27WarningsExact identifier
spl id: ec0a8e4e-cfd4-4aec-e053-2995a90a23c5
spl set id: 8f338854-1bcf-4dc4-8da2-46c3033fa042

Reported adverse events (FAERS/openFDA)#

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