FDA.reportPublic FDA data

Pure Haven Essentials

Manufacturer
Pure Haven LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:05

Label at a glance#

ProductPure Haven Essentials
Active ingredientTITANIUM DIOXIDE, ZINC 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. Reapply: - At least every tow-hours. - Immediately after swimming, sweating or towel drying. Spending time in the sun increase your risk of skin cancer and early skin aging . To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun protection measures.  - ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

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

  • 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 consult physician 

OTC - STOP USE SECTION

if irritation or rash develops. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical attention or contact poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15-minutes before sun exposure.
  • Reapply:

- At least every tow-hours.

- Immediately after swimming, sweating or towel drying.

Spending time in the sun increase your risk of skin cancer and early skin aging . To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun protection measures. 

- Limit time in the sun, especially between 10am and 2pm.

- Wear long sleeve shirts, pants, hats and sunglasses.

- For childre under 6-months, consult with a physician.

Other Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita Pepo (Pumpkin) Seed Oil, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Leuconostoc/Radish Root Ferment Filtrate, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Theobroma Cacao (Cocoa) Butter, Xanthan Gum

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sunlight.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71355-819-03Pure Haven Essentials90 mL in 1 TUBECREAM902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71355-819PURE HAVEN ESSENTIALS (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PURE HAVEN LLC]2Current NDC, Legacy NDC, 1 package rows20231112_4bccc017-266d-11ce-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71355-81971355-819-03

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
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETEARYL OLIVATE58B69Q84JOIACT
PUMPKIN SEED OIL6E5QR5USSPIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
ALMOND3Z252A2K9GIACT
SESAME OILQX10HYY4QVIACT
SORBITAN OLIVATEMDL271E3GRIACT
COCOAD9108TZ9KGIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
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
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
ndc (package): 71355-819-03
ndc (product): 71355-819
ndc11 (package): 71355081903
spl id: 09db5696-960c-d689-e063-6394a90aeb01
spl set id: 4bccc017-266d-11ce-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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