FDA.reportPublic FDA data

Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50

Manufacturer
Babo Botanicals, Inc.
Effective date
2024-05-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:29

Label at a glance#

ProductBabo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50
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

Apply liberally 15 minutes before sun exposure Use water resistant sunscreen if swimming or sweating Reapply 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 protection measures including: Limit time in the sun, especially from 10 a....

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.6%

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 a 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
  • Use water resistant sunscreen if swimming or sweating
  • Reapply 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 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), Butyloctyl Salicylate, Diheptyl Succinate, Calcium Sodium Borosilicate, Octyldodecyl Neopentanoate, Erythritol, Lauryl Laurate, Passiflora Edulis (Maracuja) Seed Oil, Propanediol, Carthamus Tinctorius (Safflower) Oleosomes, Bentonite, Aloe Barbadensis Leaf Juice*, Lupinus Albus (White Lupin) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil*, Bisabolol*, Tocopherol, Glycerin, 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*, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Hydrolyzed Wheat Protein/PVP Crosspolymer, Cetearyl Alcohol, Caprylyl Glycol, Ethyl Ferulate, Sucrose Polystearate, Capryloyl Glycerin/Sebacic Acid Copolymer, Sucrose Stearate, Coco-Glucoside, Octyldodecyl Oleate, Polyhydroxystearic Acid, Sodium Gluconate, Caprylhydroxamic Acid, Microcrystalline Cellulose, Xanthan Gum, Citric Acid, Iron Oxides.

*Certified Organic Ingredients

Questions or comments?

OTC - QUESTIONS SECTION

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

Company Information

SPL UNCLASSIFIED SECTION

Dist by Babo Botanicals, Inc.

60 East 56th Street New York, NY 10022

www.babobotanicals.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8063-1Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 501 in 1 BOXLOTION14
79265-8063-1Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 5050 mL in 1 BOTTLE, PLASTICLOTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8063BABO BOTANICALS DAILY SHEER FLUID TINTED MINERAL SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [BABO BOTANICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20240515_d66dfcec-ad40-3a0b-e053-2995a90aa006.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-806379265-8063-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSE STEARATE274KW0O50MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
LAURYL LAURATEGPW77G0937IACT
PASSIFLORA EDULIS SEED OILF3VOA31UHQIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
PROPANEDIOL5965N8W85TIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
BENTONITEA3N5ZCN45CIACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
LEVOMENOL24WE03BX2TIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHAMOMILEFGL3685T2XIACT
LUPINUS ALBUS SEED OIL958BJW095QIACT
WHEAT GERM OIL UNSAPONIFIABLES6AXM7XCV3DIACT
TOCOPHEROLR0ZB2556P8IACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SUNFLOWER OIL3W1JG795YIIACT
RASPBERRY SEED OIL9S8867952AIACT
SODIUM GLUCONATER6Q3791S76IACT
ETHYL FERULATE5B8915UELWIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
COCO GLUCOSIDEICS790225BIACT
ERYTHRITOLRA96B954X6IACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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 Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.d66dfcec-ad40-3a0b-e053-2995a90aa0062024-05-14WarningsExact identifier
ndc (package): 79265-8063-1
ndc (product): 79265-8063
ndc11 (package): 79265806301
spl id: 186a3faf-e5fe-ef88-e063-6294a90ae8b6
spl set id: d66dfcec-ad40-3a0b-e053-2995a90aa006

Reported adverse events (FAERS/openFDA)#

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