FDA.reportPublic FDA data

Sun and Honey

Manufacturer
Amara Ventures
Effective date
2025-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:53

Label at a glance#

ProductSun and Honey
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 generously and evenly 15 minutes before sun exposure reapply at least every 2 hours  use a water resistant sunscreen if swimming or sweating 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protec...

Label contents#

Full prescribing information#

Active Ingredient                                       Purpose

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10%                                         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 useon broken or damaged skin. 
  • When using this product keep out of eyes. Rinse with water to remove. 
  • Stop use and ask a doctor ifrash occurs.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours 
  • use a water resistant sunscreen if swimming or sweating
  • 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 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Tallow, Simmondsia Chinensis (Jojoba) Oil Jojoba Esters, Organic Propolis, Organic Cera Alba (Beeswax), Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Salix Alba (Willow Bark) Extract, Xanthan Gum, Glycerin, Gluconolactone & Sodium Benzoate (Geogard Ultra), Potassium Sorbate.

Other Information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun
  • Do not use if the seal is broken

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
85432-001-01Sun and Honey1 in 1 BOXCREAM12
85432-001-01Sun and Honey100 g in 1 TUBECREAM1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85432-001SUN AND HONEY (ZINC OXIDE) CREAM [AMARA VENTURES]22 package rows20250410_49fcf429-332f-43b3-aab0-d2a5b95f4571.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85432-00185432-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TALLOW98HPY76U4WIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
PROPOLIS WAX6Y8XYV2NOFIACT
YELLOW WAX2ZA36H0S2VIACT
TOCOPHEROLR0ZB2556P8IACT
SUNFLOWER SEEDR9N3379M4ZIACT
RICE BRANR60QEP13ICIACT
SALIX ALBA BARK205MXS71H7IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
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
3248618f-6c96-4076-e063-6294a90a6d9249fcf429-332f-43b3-aab0-d2a5b95f45712025-04-08WarningsExact identifier
spl id: 3248618f-6c96-4076-e063-6294a90a6d92
spl set id: 49fcf429-332f-43b3-aab0-d2a5b95f4571

Reported adverse events (FAERS/openFDA)#

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