FDA.reportPublic FDA data

Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50

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 00:43:41

Label at a glance#

ProductBabo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50
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 two 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 sun protection measures including: Limit time in the s...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24.5%

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 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 immediately.

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 two 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 sun 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 of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Tapioca Starch, Saccharomyces Ferment, Behenyl Behenate, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Passiflora Edulis (Maracuja) Seed Oil, Bentonite, Butyrospermum Parkii (Shea) Butter, Tocopherol (Vitamin E), 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, Lauroyl Lysine, Euphorbia Cerifera (Candelilla) Wax, Acacia Decurrens Flower Wax, Polyglyceryl-10 Diisosterate, Polyglycerin-3.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-422-2987 M-F

9:00am - 5:00pm EST

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8776-1Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 501 in 1 CARTONSALVE12
79265-8776-1Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 5056 g in 1 CANSALVE562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8776BABO BOTANICALS SWIM AND SPORT MINERAL SUNSCREEN BALM SPF 50 (ZINC OXIDE) SALVE [BABO BOTANICALS, INC.]2Current NDC, 2 package rows20241215_f8b272f6-8726-de1d-e053-6294a90a7b1e.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
79265-877679265-8776-1

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
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
BENTONITEA3N5ZCN45CIACT
SHEA BUTTERK49155WL9YIACT
LAUROYL LYSINE113171Q70BIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
PASSIFLORA EDULIS SEED OILF3VOA31UHQIACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
BEHENYL BEHENATEK8NU647RJ0IACT
CANDELILLA WAXWL0328HX19IACT
SUNFLOWER OIL3W1JG795YIIACT
POLYGLYCERIN-34A0NCJ6RD6IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
TOCOPHEROLR0ZB2556P8IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ZINC OXIDESOI2LOH54ZACTIB
CHAMOMILEFGL3685T2XIACT
NASTURTIUM OFFICINALEYH89GMV676IACT
STARCH, TAPIOCA24SC3U704IIACT

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 Swim and Sport Mineral Sunscreen Balm SPF 50ZINC OXIDEBabo Botanicals, Inc.f8b272f6-8726-de1d-e053-6294a90a7b1e2024-12-12WarningsExact identifier
ndc (package): 79265-8776-1
ndc (product): 79265-8776
ndc11 (package): 79265877601
spl id: 29157a2b-17da-9cf6-e063-6394a90a1bbf
spl set id: f8b272f6-8726-de1d-e053-6294a90a7b1e

Reported adverse events (FAERS/openFDA)#

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