FDA.reportPublic FDA data

SPF 50 Super Shield Sport Sunscreen

Manufacturer
Babo Botanicals, Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:30

Label at a glance#

ProductSPF 50 Super Shield Sport Sunscreen
Active ingredientZINC OXIDE
Label structure17 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 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#

Primary Container Labeling

SPL UNCLASSIFIED SECTION

79265-8098-1 17 g

Inner Container LabelInner Container Label

79265-8098 SPF 50 Super Shield Sport Stick Sunscreen

SPL UNCLASSIFIED SECTION

Sunscreen product manufactured pursuant to the Final Monograph. Active ingredient Zinc Oxide.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 17.363%

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.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

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

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 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

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

BEESWAX*
BISABOLOL
BUTYROSPERMUM PARKII (SHEA) BUTTER*
CALOPHYLLUM TACAMAHACA SEED OIL*
CANNABIS SATIVA SEED OIL*
EUPHORBIA CERIFERA (CANDELILLA) WAX
JOJOBA ESTERS
OCTYLDODECYL OLEATE
ORYZA SATIVA (RICE) BRAN OIL*
ORYZANOL
PERSEA GRATISSIMA (AVOCADO) OIL*
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*
THEOBROMA CACAO (COCOA) SEED BUTTER*
TOCOPHEROL

*Certified Organic ingredient

Other Information

OTHER SAFETY INFORMATION

Other 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

INFORMATION PANELINFORMATION PANEL

DRUG FACTS PANEL

SPL UNCLASSIFIED SECTION

Drug Facts Panel PART 1Drug Facts Panel PART 1

Drug Facts Panel PART 2Drug Facts Panel PART 2

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79265-8098-0

Babo Botanicals

Super Shield Sport Stick

Broad Spectrum Sunscreen SPF 50

100% Zinc Oxide Active Ingredient

80 Minute Water & Sweat Resistant

Ultra Sheer & Hypoallergenic

Fragrance Free

Outer Package BoxOuter Package Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8098-0SPF 50 Super Shield Sport Sunscreen1 in 1 BOXSTICK15
79265-8098-1SPF 50 Super Shield Sport Sunscreen17 g in 1 CYLINDERSTICK175

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8098SPF 50 SUPER SHIELD SPORT SUNSCREEN (MINERAL SUNSCREEN) STICK [BABO BOTANICALS, INC.]5Legacy NDC, 2 package rows20241215_b3e4900f-5e45-6e24-e053-2a95a90ae53a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-809879265-8098-1, 79265-8098-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
RICE BRAN OILLZO6K1506AIACT
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
ORYZANOLSST9XCL51MIACT
WHITE WAX7G1J5DA97FIACT
CANDELILLA WAXWL0328HX19IACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
TOCOPHEROLR0ZB2556P8IACT
LEVOMENOL24WE03BX2TIACT
CALOPHYLLUM TACAMAHACA SEED OIL05G85L61OEIACT
COCOA BUTTER512OYT1CRRIACT
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
291a591b-2272-fdf1-e063-6294a90a172cb3e4900f-5e45-6e24-e053-2a95a90ae53a2024-12-12WarningsExact identifier
spl id: 291a591b-2272-fdf1-e063-6294a90a172c
spl set id: b3e4900f-5e45-6e24-e053-2a95a90ae53a

Reported adverse events (FAERS/openFDA)#

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