FDA.reportPublic FDA data

Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30

Manufacturer
Babo Botanicals, Inc.
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:58:24

Label at a glance#

ProductBabo Botanicals Sheer Zinc 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 Hold container 4 to 6 inches from the skin to apply Apply liberally 15 minutes before sun exposure Do not spray directly into face Spray into hands and then apply to face Do not spray in windy condition Use in well ventilated area 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...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

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.

  • Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

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 a doctor if

OTC - STOP USE SECTION

  • 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
  • Hold container 4 to 6 inches from the skin to apply
  • Apply liberally 15 minutes before sun exposure
  • Do not spray directly into face
  • Spray into hands and then apply to face
  • Do not spray in windy condition
  • Use in well ventilated area
  • 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. - 2P.M.
  • Wear long sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Butyloctyl Salicylate, Bentonite, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Methyl Dihydroabietate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Jojoba Esters, 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*, Glycerin, Coco-Glucoside, Caprylyl Glycol, Caprylhydroxamic Acid, Cetearyl Alcohol.

*Certified Organic Ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-422-2987 Mon - Fri 9:00AM - 5:00PM EST

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-7908-1Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30177 mL in 1 CANSPRAY1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-7908BABO BOTANICALS SHEER ZINC MINERAL SUNSCREEN SPF30 (ZINC OXIDE) SPRAY [BABO BOTANICALS, INC.]1Current NDC, 1 package rows20231031_08f0f32e-4b19-7a62-e063-6394a90af1b1.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-790879265-7908-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHAMOMILEFGL3685T2XIACT
SUNFLOWER OIL3W1JG795YIIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
BENTONITEA3N5ZCN45CIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
SAFFLOWER OIL65UEH262ISIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
COCO GLUCOSIDEICS790225BIACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
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 Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0f32e-4b19-7a62-e063-6394a90af1b12023-10-30WarningsExact identifier
ndc (package): 79265-7908-1
ndc (product): 79265-7908
ndc11 (package): 79265790801
spl id: 08f10c8d-2da2-bc7f-e063-6294a90aed61
spl set id: 08f0f32e-4b19-7a62-e063-6394a90af1b1

Reported adverse events (FAERS/openFDA)#

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