FDA.reportPublic FDA data

Natural Hydrating Shield SPF 30

Manufacturer
Group Fourteen Operations Pty Limited
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:26

Label at a glance#

ProductNatural Hydrating Shield SPF 30
Active ingredientZINC OXIDE
Label structure7 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. 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. Reapply at...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.5%

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 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 - STOP USE 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.
  • 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.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Castor Oil, Rosehip Oil, English Lavender Oil, Parsley Seed Oil, Sodium Hyaluronate, Candelilla Wax, Coco-Caprylate/
Caprate, Polyglyceryl-3 Polyricinoleate, Coconut Oil, Tocopheryl Acetate, Isostearic Acid, Linalool.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

Bottle1Bottle1

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
79228-0000-02025-07-29C16284748780-13b156c62-2cbe-fb37-e063-e6dba90a4e07Natural Hydrating Shield SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79228-0000-0Natural Hydrating Shield SPF 3050 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79228-0000NATURAL HYDRATING SHIELD SPF 30 (ZINC OXIDE) CREAM [GROUP FOURTEEN OPERATIONS PTY LIMITED]2Legacy NDC, 1 package rows20231222_be37a679-b490-4093-972b-fb12eeda7a24.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79228-000079228-0000-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CASTOR OILD5340Y2I9GIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
ENGLISH LAVENDER OILZBP1YXW0H8IACT
PARSLEY SEED OILXB8Q500O0ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CANDELILLA WAXWL0328HX19IACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
COCONUT OILQ9L0O73W7LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOSTEARIC ACIDX33R8U0062IACT
LINALOOL, (+/-)-D81QY6I88EIACT
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
0d0d2fbf-6dae-7240-e063-6294a90acb2fbe37a679-b490-4093-972b-fb12eeda7a242023-12-21WarningsExact identifier
spl id: 0d0d2fbf-6dae-7240-e063-6294a90acb2f
spl set id: be37a679-b490-4093-972b-fb12eeda7a24

Reported adverse events (FAERS/openFDA)#

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