SPF 50 Tinted Face Mineral Fragrance Free Sunscreen

Manufacturer
Babo Botanicals, Inc. | Bell International Laboratories
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:29

Label at a glance#

ProductSPF 50 Tinted Face Mineral Fragrance Free Sunscreen
Active ingredientZINC OXIDE
Label structure17 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

DIRECTIONS Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying

Label contents#

Full prescribing information#

79265-8068-0 SPF 50 Tinted Face Mineral Fragrance Free Sunscreen Stick

SPL UNCLASSIFIED SECTION

This product is a mineral sunscreen semi solid stick manufactured pursuant to the sunscreen final monograph.

Primary Container Label

SPL UNCLASSIFIED SECTION

79265-8068-1

Primary container labelingPrimary container labeling

DRUG FACTS PANEL

SPL UNCLASSIFIED SECTION

79265-8068-0

Drug Facts PanelDrug Facts Panel

Drug Facts Panel 2Drug Facts Panel 2

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.2115%

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.

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

WARNINGS

WARNINGS SECTION

Warnings • For external use only. | Do not use on damaged or broken skin. | When using this product Keep out of eyes. Rinse with water to remove. | Stop use and ask doctor if rash occurs. | Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away

DO NOT USE

OTC - DO NOT USE SECTION

Do not use on damaged 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 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 a product is swallowed get medical help or contact a Poison Control center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ARGANIA SPINOSA KERNEL EXTRACT, BEESWAX*, BISABOLOL*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, CALENDULA OFFICINALIS FLOWER EXTRACT*, CALOPHYLLUM INOPHYLLUM SEED OIL*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COFFEA ARABICA (COFFEE) SEED EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, HIPPOPHAE RHAMNOIDES FRUIT EXTRACT, IRON OXIDES, JOJOBA ESTERS, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, OCTYLDODECANOL, OCTYLDODECYL OLEATE, ORYZANOL, ORYZA SATIVA (RICE) BRAN OIL*, PERSEA GRATISSIMA (AVOCADO) OIL*, PUERARIA LOBATA ROOT EXTRACT*, ROSA CANINA FRUIT EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, TRIHYDROXYSTEARIN.

*CERTIFIED ORGANIC INGREDIENT

OTHER INFORMATION

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS / COMMENTS?

SPL UNCLASSIFIED SECTION

Questions and comments: Call 1-877-537-BABO

INFORMATION PANEL

SPL UNCLASSIFIED SECTION

79265-8068-0 INFORMATION PANEL

INFORMATION PANELINFORMATION PANEL

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.6 oz. 17 g 79265-8068-0

Outer Package BoxOuter Package Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8068-0SPF 50 Tinted Face Mineral Fragrance Free Sunscreen1 in 1 BOXSTICK13
79265-8068-1SPF 50 Tinted Face Mineral Fragrance Free Sunscreen17 g in 1 CYLINDERSTICK173

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8068SPF 50 TINTED FACE MINERAL FRAGRANCE FREE SUNSCREEN (MINERAL SUNSCREEN) STICK [BABO BOTANICALS, INC.]3Legacy NDC, 2 package rows20241215_b20d4019-643b-60fe-e053-2a95a90a8729.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
79265-806879265-8068-1, 79265-8068-0

Ingredients#

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

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

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
291a0b0a-c256-28b7-e063-6294a90a7e2bb20d4019-643b-60fe-e053-2a95a90a87292024-12-12WarningsExact identifier
spl id: 291a0b0a-c256-28b7-e063-6294a90a7e2b
spl set id: b20d4019-643b-60fe-e053-2a95a90a8729

Reported adverse events (FAERS/openFDA)#

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