FDA.reportPublic FDA data

Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40

Manufacturer
Babo Botanicals, Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:39

Label at a glance#

ProductBabo Botanicals Daily Sheer Mineral Sunscreen SPF 40
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure7 sections

Indications and uses

• Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor use a water resistant sunscreen if swimming or sweating reapply: immediately after towel drying at least every 2 hours Sun Protection Measures Sun exposure increases risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5.9%

Zinc Oxide 3.3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

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 doctor

OTC - STOP USE SECTION

  • if 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. Children under 6 months of age: Ask a doctor
  • use a water resistant sunscreen if swimming or sweating
  • reapply:
  • immediately after towel drying
  • at least every 2 hours

Sun Protection Measures Sun exposure increases risk of skin cancer and early skin aging. To decrease 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 10a.m. - 2p.m. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice*, Aluminum Hydroxide, Beeswax*, Butyrospermum Parkii (Shea Butter)*, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Coco-Glucoside, Dehydroxanthan Gum, Dicaprylyl Carbonate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrogen Dimethicone, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methyl Dihydroabietate, Myristyl Alcohol, Myristyl Glucoside, Persea Gratissima (Avocado) Oil, Phenethyl Alcohol, Pongamia Pinnata Seed Oil, Ricinus Communis (Castor) Seed Oil, Rosa Canina Fruit Extract, Simmondsia Chinensis (Jojoba) Seed Oil*, Triethoxycaprylylsilane, Water (Aqua).

*Certified Organic Ingredients

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8708-1Babo Botanicals Daily Sheer Mineral Sunscreen SPF 4050 mL in 1 TUBELOTION502
79265-8708-1Babo Botanicals Daily Sheer Mineral Sunscreen SPF 401 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8708BABO BOTANICALS DAILY SHEER MINERAL SUNSCREEN SPF 40 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [BABO BOTANICALS, INC.]22 package rows20241215_ee005198-56e2-1739-e053-2a95a90a7659.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-870879265-8708-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
JOJOBA OIL724GKU717MIACT
CASTOR OILD5340Y2I9GIACT
ROSA CANINA FRUIT3TNW8D08V3IACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
SUNFLOWER OIL3W1JG795YIIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
AVOCADO OIL6VNO72PFC1IACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
MYRISTYL ALCOHOLV42034O9PUIACT
MYRISTYL GLUCOSIDE6AK28695LFIACT
KARUM SEED OIL62160PU6FJIACT
COCO GLUCOSIDEICS790225BIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
ZINC OXIDESOI2LOH54ZACTIB
YELLOW WAX2ZA36H0S2VIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
GREEN TEA LEAFW2ZU1RY8B0IACT

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
291a1416-ecd3-dc95-e063-6394a90aabe7ee005198-56e2-1739-e053-2a95a90a76592024-12-12WarningsExact identifier
spl id: 291a1416-ecd3-dc95-e063-6394a90aabe7
spl set id: ee005198-56e2-1739-e053-2a95a90a7659

Reported adverse events (FAERS/openFDA)#

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