FDA.reportPublic FDA data

People4Ocean SPF50 sunscreen

Manufacturer
P4O Distribution Pty Ltd
Effective date
2020-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:52

Label at a glance#

ProductPeople4Ocean SPF50 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 22.5%

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 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

Purified water, Coco-Caprylate/Caprate, Caprilic/capric triglycerideº, Polyglyceryl-3 Polyricinoleate, Dimethicone, Octyl Palmitate, Isostearic Acidº, Butylene glycol, PEG-30 dipolyhydroxystearate, Beeswaxº, Glycerol, Polyethylene, Phenoxyethanol, Glyceryl oleate, Ethylhexylglycerin, Lavender Oil*, Ylang Ylang Flower Oil*, Patchouli Leaf Oil*, Vetiver Root Oil*, Geranium Oil*, Xanthan gum. ºOrganic | *Natural.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

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
73192-030-002024-01-30C16284748780-11030e365-1e44-111a-e063-dadaa90a10e2People4Ocean SPF50 sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73192-030-00People4Ocean SPF50 sunscreen1000 mL in 1 BOTTLE, PUMPLOTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73192-030PEOPLE4OCEAN SPF50 SUNSCREEN (ZINC OXIDE) LOTION [P4O DISTRIBUTION PTY LTD]1Legacy NDC, 1 package rows20200702_d21fb067-35c0-411c-828a-344ec4a84bb6.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73192-03073192-030-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERINPDC6A3C0OXIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL OLEATE4PC054V79PIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LAVENDER OILZBP1YXW0H8IACT
CANANGA OIL8YOY78GNNXIACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL PALMITATE2865993309IACT
ISOSTEARIC ACIDX33R8U0062IACT
BUTYLENE GLYCOL3XUS85K0RAIACT

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
a95e19d7-6ae6-2870-e053-2995a90ae4acd21fb067-35c0-411c-828a-344ec4a84bb62020-07-01WarningsExact identifier
spl id: a95e19d7-6ae6-2870-e053-2995a90ae4ac
spl set id: d21fb067-35c0-411c-828a-344ec4a84bb6

Reported adverse events (FAERS/openFDA)#

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