8579 Babo SPF 30 Baby Skin Mineral Non-Aerosol Sunscreen Pump Spray, FF

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 00:43:29

Label at a glance#

ProductBabo Baby Skin Mineral Sunscreen FF
Active ingredientZINC OXIDE
Label structure14 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. 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: Li...

Label contents#

Full prescribing information#

SPF 30 Baby Skin Mineral Non-Aerosol Sunscreen Pump Spray, FF

SPL UNCLASSIFIED SECTION

This product is an OTC sunscreen manufactured according to the Sunscreen Final Rule. Active ingredient: Zinc Oxide

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.5%; Purpose: 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

Purpose

OTC - PURPOSE SECTION

Sunscreen

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 eye. Rinse with water to remove.

Stop use and ask doctor

OTC - STOP USE SECTION

if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If 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.

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. and wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months; ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

BENTONITE
BISABOLOL*
BUTYLOCTYL SALICYLATE
CALENDULA OFFICINALIS FLOWER EXTRACT*
CAPRYLHYDROXAMIC ACID
CAPRYLIC/CAPRIC TRIGLYCERIDE
CAPRYLYL GLYCOL
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL
CELLULOSE GUM
CETEARYL ALCOHOL
CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*
COCO GLUCOSIDE
GLYCERIN*
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*
JOJOBA ESTERS
METHYL DIHYDROABIETATE
MICROCRYSTALLINE CELLULOSE
NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*
POLYHYDROXYSTEARIC ACID
PROPANEDIOL
PUERARIA LOBATA (KUDZU) ROOT EXTRACT*
SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*
TETRADECANE
TOCOPHEROL
WATER (AQUA)

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.

Questions and comments

SPL UNCLASSIFIED SECTION

Call toll free 1-877-537-BABO Monday-Friday 9:00 am - 5:00 EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79265-8579-6 6 fl. oz. / 177 mL

8579 Front and Drug Facts Panel8579 Front and Drug Facts Panel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8579-6Babo Baby Skin Mineral Sunscreen FF177 mL in 1 BOTTLE, SPRAYSPRAY1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8579BABO BABY SKIN MINERAL SUNSCREEN FF (MINERAL SUNSCREEN) SPRAY [BABO BOTANICALS, INC.]5Legacy NDC, 1 package rows20241215_b0a513a5-18d4-5fca-e053-2a95a90aef93.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-857979265-8579-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
291a09aa-9f03-343b-e063-6294a90a5130b0a513a5-18d4-5fca-e053-2a95a90aef932024-12-12WarningsExact identifier
spl id: 291a09aa-9f03-343b-e063-6294a90a5130
spl set id: b0a513a5-18d4-5fca-e053-2a95a90aef93

Reported adverse events (FAERS/openFDA)#

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