FDA.reportPublic FDA data

Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 30

Manufacturer
Babo Botanicals, Inc.
Effective date
2026-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:10

Label at a glance#

ProductBabo Botanicals Hydrating Milk Mineral Sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure10 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 40 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...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts enclosed

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 17%

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 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
  • Apply liberally 15 minutes before sun exposure
  • Reapply after 40 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), Caprylic/Capric Triglyceride, C13-15 Alkane, Coco-Caprylate/Caprate, Polyglyceryl-6 Polyricinoleate, Propanediol, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Polyglyceryl-10 Dioleate, Sodium Chloride, Passiflora Edulis (Maracuja) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Caprylhydroxamic Acid, Xanthan Gum, 1,2-Hexanediol.

*CERTIFIED ORGANIC INGREDIENTS

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-422-2987 M-F 9:00AM - 5:00PM EST

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8164-0Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 3059 mL in 1 TUBELOTION591

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
79265-816479265-8164-0

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
C13-15 ALKANE114P5I43UJIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
PROPANEDIOL5965N8W85TIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERYL-10 DIOLEATE598RES7AXXIACT
PASSIFLORA EDULIS SEED OILF3VOA31UHQIACT
CHAMOMILEFGL3685T2XIACT
WATER059QF0KO0RIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIB
SODIUM CHLORIDE451W47IQ8XIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
NASTURTIUM OFFICINALEYH89GMV676IACT

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 Hydrating Milk Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.4db37efb-2d37-7428-e063-6394a90a10e42026-03-23WarningsExact identifier
ndc (package): 79265-8164-0
ndc (product): 79265-8164
ndc11 (package): 79265816400
spl id: 4db37efb-2d38-7428-e063-6394a90a10e4
spl set id: 4db37efb-2d37-7428-e063-6394a90a10e4

Reported adverse events (FAERS/openFDA)#

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