FDA.reportPublic FDA data

People4Ocean SPF30 Sunscreen

Manufacturer
P4O Distribution Pty Ltd
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:10:55

Label at a glance#

ProductPeople4Ocean SPF30 Sunscreen
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 and evenly 15 minutes before sun exposure Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 22%

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 and evenly 15 minutes before sun exposure
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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
  • children under 6 months of age: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store below 86°F (30°C)
  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

caprylic/capric triglyceride, grape seed oil, beeswax, shea butter, candelilla wax, soybean oil, glyceryl isostearate, polyhydroxystearic acid, jojoba seed oil, tocopherol, safflower seed oil, english lavender oil, ylang ylang flower oil, patchouli leaf oil, vetiver root oil, geranium oil, cucumber fruit extract, carrot root extract, beta-carotene, rose hip fruit oil

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73192-010-022024-01-30C16284748780-11030e365-0e52-111a-e063-dadaa90a10e2People4Ocean SPF30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73192-010-02People4Ocean SPF30 Sunscreen200 mL in 1 TUBECREAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73192-010PEOPLE4OCEAN SPF30 SUNSCREEN (ZINC OXIDE) CREAM [P4O DISTRIBUTION PTY LTD]2Legacy NDC, 1 package rows20200513_96700ded-bccb-4d7a-a7ea-f4b4bcbc3879.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73192-01073192-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA CAROTENE01YAE03M7JIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
ZINC OXIDESOI2LOH54ZACTIM
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GRAPE SEED OIL930MLC8XGGIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
CANDELILLA WAXWL0328HX19IACT
SOYBEAN OIL241ATL177AIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
SAFFLOWER OIL65UEH262ISIACT
LAVENDER OILZBP1YXW0H8IACT
CANANGA OIL8YOY78GNNXIACT
VETIVER OIL9M9P32M01LIACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
CARROTL56Z1JK48BIACT

Source Document#

Source XML · Source PDF

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
a5749b82-d845-2b03-e053-2995a90a379396700ded-bccb-4d7a-a7ea-f4b4bcbc38792020-05-12WarningsExact identifier
spl id: a5749b82-d845-2b03-e053-2995a90a3793
spl set id: 96700ded-bccb-4d7a-a7ea-f4b4bcbc3879

Reported adverse events (FAERS/openFDA)#

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