FDA.reportPublic FDA data

Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30

Manufacturer
Babo Botanicals, Inc.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:57:56

Label at a glance#

ProductBabo Botanicals Sensitive Baby Mineral Sunscreen SPF30
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

Shake well 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 t...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.5%

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

  • Shake well
  • 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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil*, Butyloctyl Salicylate, Tetradecane, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Methyl Dihydroabietate, Bentonite, Cetearyl Alcohol, Propanediol, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale Flower/Leaf Extract*, Spiraea Ulmaria Flower Extract*, Glycerin, Jojoba Esters, Bisabolol*, Tocopherol, Caprylyl Glycol, Microcrystalline Cellulose, Coco-Glucoside, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Cellulose Gum.

*Certified Organic Ingredients

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

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-9758-1Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30177 mL in 1 BOTTLE, SPRAYSPRAY1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-9758BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF30 (ZINC OXIDE) SPRAY [BABO BOTANICALS, INC.]1Current NDC, 1 package rows20231027_08a36887-3997-8fff-e063-6394a90ae9d5.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-975879265-9758-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRADECANE03LY784Y58IACT
WATER059QF0KO0RIACT
BENTONITEA3N5ZCN45CIACT
CAPRYLYL GLYCOL00YIU5438UIACT
LEVOMENOL24WE03BX2TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHAMOMILEFGL3685T2XIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
PROPANEDIOL5965N8W85TIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
COCO GLUCOSIDEICS790225BIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
TOCOPHEROLR0ZB2556P8IACT
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 SPF30ZINC OXIDEBabo Botanicals, Inc.08a36887-3997-8fff-e063-6394a90ae9d52023-10-26WarningsExact identifier
ndc (package): 79265-9758-1
ndc (product): 79265-9758
ndc11 (package): 79265975801
spl id: 08a348a0-00a1-4f33-e063-6394a90ad6ed
spl set id: 08a36887-3997-8fff-e063-6394a90ae9d5

Reported adverse events (FAERS/openFDA)#

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