FDA.reportPublic FDA data

Happy Farm Botanicals Protective Day Cream SPF 30

Manufacturer
Happy Farm Botanicals, Inc.
Effective date
2022-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:04

Label at a glance#

ProductHappy Farm Botanicals Protective Day Cream SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure12 sections

Indications and uses

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

Shake well Apply liberally 15 minutes before sun exposure Reapply: After 40 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 of 15 or higher and other sun protection measures including: Limit time in th...

Label contents#

Full prescribing information#

Active Ingredients Section

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Non-Nano Uncoated Zinc Oxide, 2.34%

Titanium Dioxide, 3.60%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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.

Warnings

WARNINGS SECTION

Warnings

For external use only

Do not use on damage or broken skin.

Do Not Use

OTC - DO NOT USE SECTION

Do not use on damage or broken skin

When using this product

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

Stop Use and ask a Doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

Keep out of reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children. If product is swallowed get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • After 40 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 of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10:00 am – 2:00 pm.\
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Caprylic/Capric Triglycerides, Pentylene Glycol, Sorbitan Oleate Decylglucoside Crosspolymer, Glycerin, Ethyl Lauroyl Arginate HCl, VP/Eicosene Copolymer, Glyceryl Strearate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROTECTIVE DAY CREAM SUNSCREEN SPF 30PROTECTIVE DAY CREAM SUNSCREEN SPF 30LABEL PROTECTIVE DAY CREAM MINERAL SUNSCREEN SPF 30LABEL PROTECTIVE DAY CREAM MINERAL SUNSCREEN SPF 30

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73964-030-012024-01-30C16284748780-11030e365-27f6-111a-e063-dadaa90a10e2Sunscreen Product Listing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73964-030-01Happy Farm Botanicals Protective Day Cream SPF 30236 g in 1 BOTTLE, PUMPCREAM2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73964-030HAPPY FARM BOTANICALS PROTECTIVE DAY CREAM SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [HAPPY FARM BOTANICALS, INC.]1Legacy NDC, 1 package rows20220406_dbebb4d2-db6e-e6f6-e053-2a95a90ae6e1.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73964-03073964-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT)XQQ9MKE2BJIACT
PENTYLENE GLYCOL50C1307PZGIACT
C12-15 ALKYL ETHYLHEXANOATEGQJ580CH83IACT
WATER059QF0KO0RIACT
SORBETH-12/OLEATE/DIMER DILINOLEATE CROSSPOLYMER6287108Q5RIACT
XANTHAN GUMTTV12P4NEEIACT
ETHYL LAUROYL ARGINATE HYDROCHLORIDEXPD6ZY79TBIACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
dbebb4a3-d74a-21ca-e053-2a95a90ae2f7dbebb4d2-db6e-e6f6-e053-2a95a90ae6e12022-02-09WarningsExact identifier
spl id: dbebb4a3-d74a-21ca-e053-2a95a90ae2f7
spl set id: dbebb4d2-db6e-e6f6-e053-2a95a90ae6e1

Reported adverse events (FAERS/openFDA)#

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