FDA.reportPublic FDA data

Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50

Manufacturer
Babo Botanicals, Inc.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:57:38

Label at a glance#

ProductBabo Botanicals Sensitive Baby Mineral Sunscreen SPF50
Active ingredientZINC OXIDE
Label structure9 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 after 80 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 SPF of 15 or higher and other protection measures including: Limit time in the sun, espe...

Storage and handling

Protect this product from excessive heat and direct sun. May stain some fabrics and surfaces.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.7%

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 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 a 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.
  • Reapply after 80 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 SPF of 15 or higher and other protection measures including:
  • Limit time in the sun, especially from 10 a.m. – 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics and surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Oleate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Butyrospermum Parkii (Shea) Butter*, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Calophyllum Inophyllum (Tamanu) Seed Oil*, Tocopherol.

*Certified Organic Ingredients

Company Information

SPL UNCLASSIFIED SECTION

Dist: by Babo Botanicals, Inc.
60 East 56th Street New York, NY 10022

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-5608-1Babo Botanicals Sensitive Baby Mineral Sunscreen SPF5017 g in 1 TUBESTICK171
79265-5608-1Babo Botanicals Sensitive Baby Mineral Sunscreen SPF501 in 1 CARTONSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-5608BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF50 (ZINC OXIDE) STICK [BABO BOTANICALS, INC.]1Current NDC, 2 package rows20231026_088b81e4-76c7-6680-e063-6294a90acb73.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
79265-560879265-5608-1

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
TAMANU OILJT3LVK84A1IACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
ORYZANOLSST9XCL51MIACT
WHITE WAX7G1J5DA97FIACT
CHAMOMILEFGL3685T2XIACT
LEVOMENOL24WE03BX2TIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CANDELILLA WAXWL0328HX19IACT
SHEA BUTTERK49155WL9YIACT
RICE BRAN OILLZO6K1506AIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
COCOA BUTTER512OYT1CRRIACT
CALOPHYLLUM TACAMAHACA SEED OIL05G85L61OEIACT
SUNFLOWER OIL3W1JG795YIIACT
AVOCADO OIL6VNO72PFC1IACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.088b81e4-76c7-6680-e063-6294a90acb732023-10-25WarningsExact identifier
ndc (package): 79265-5608-1
ndc (product): 79265-5608
ndc11 (package): 79265560801
spl id: 088bacc1-0191-4745-e063-6394a90a67c0
spl set id: 088b81e4-76c7-6680-e063-6294a90acb73

Reported adverse events (FAERS/openFDA)#

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