FDA.reportPublic FDA data

PURE HAVEN BODY SPF 30

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 00:00:08

Label at a glance#

ProductPURE HAVEN BODY SPF 30
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 two-hours. - Immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this riks, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, espe...

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: For external use

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 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 two-hours. - Immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this riks, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, especially between 10am and 2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, cansult a physician.




SUN PROTECTION MEASURES.

Other ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tree) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita, Glycerin, Glyceryl Stearate, Heliathus 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

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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71355-349-00PURE HAVEN BODY SPF 3090 mL in 1 TUBECREAM902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71355-349PURE HAVEN BODY SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PURE HAVEN, LLC]2Current NDC, Legacy NDC, 1 package rows20231112_6f298fcd-8a97-8f66-e053-2991aa0adb10.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71355-34971355-349-00

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
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETEARYL OLIVATE58B69Q84JOIACT
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 BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
ndc (package): 71355-349-00
ndc (product): 71355-349
ndc11 (package): 71355034900
spl id: 09db452d-6f86-5ec1-e063-6294a90a1e14
spl set id: 6f298fcd-8a97-8f66-e053-2991aa0adb10

Reported adverse events (FAERS/openFDA)#

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