FDA.reportPublic FDA data

ZINC OXIDE

Manufacturer
POOLBAR
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:38:03

Label at a glance#

ProductPool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla Scented
Active ingredientZINC OXIDE
Label structure7 sections

Dosage and administration

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 of age: Ask a doctor Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

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
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • Sun protection measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF 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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Sorbitan Sesquioleate, Butyloctyl Salicylate, Polysorbate 20, Polysorbate 80, C12-15 Alkyl Benzoate, Glyceryl Stearate SE, Propylene Glycol, Aloe Barbadensis Leaf Juice, Capryloyl Glycerin/Sebacic Acid Copolymer, Polyhydroxystearic Acid, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Dodecane, 3-O-Ethyl Ascorbic Acid, Glycerin, Beta-Carotene, Glycine Soja (Soyabean) Oil, Sodium Stearoyl Glutamate, Dehydroacetic Acid, Xanthan Gum, Tococpheryl Acetate, Magnesium Sulfate, Benzyl Alcohol, Citric Acid, Fragrance

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84953-563-00Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla Scented140 mL in 1 TUBECREAM1401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84953-563POOL BAR LONDON I SCREAM FOR SUNSCREEN HYDRATING MINERAL BODY CREAM SPF 30 COCONUT AND VANILLA SCENTED (ZINC OXIDE) CREAM [POOLBAR]1Current NDC, 1 package rows20241121_3a481521-e209-4c86-895f-2e7392b7c565.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84953-56384953-563-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 806OZP39ZG8HIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
COCOA BUTTER512OYT1CRRIACT
DODECANE11A386X1QHIACT
3-O-ETHYL ASCORBIC ACID6MW60CB71PIACT
GLYCERINPDC6A3C0OXIACT
BETA-CAROTENE01YAE03M7JIACT
SOYBEAN OIL241ATL177AIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
DEHYDROACETIC ACID2KAG279R6RIACT
XANTHAN GUMTTV12P4NEEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MAGNESIUM SULFATEDE08037SABIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR3a481521-e209-4c86-895f-2e7392b7c5652024-11-19WarningsExact identifier
ndc (package): 84953-563-00
ndc (product): 84953-563
ndc11 (package): 84953056300
spl id: 2740cb5d-f5f7-44c1-e063-6394a90a364a
spl set id: 3a481521-e209-4c86-895f-2e7392b7c565

Reported adverse events (FAERS/openFDA)#

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