FDA.reportPublic FDA data

Baby Donna SHeer SPF Sunscreen Stick

Manufacturer
BabyDonna LLC
Effective date
2023-02-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:18

Label at a glance#

ProductBaby Donna SHeer SPF Sunscreen Stick
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn.  If used as directed with other 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 15min before sun exposure. Reapply after 80mins of swimming or sweating immediately after towel drying and at least every 2 hrs. For children under 6 months of age ; ask a doctor. 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 value of 15 or higher and other sun prot...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn. 
  • If used as directed with other 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 on damaged or broken skin.
  • When using this product, Keep out of eyes. Rinse with water to remove.
  • stop use and ask doctor if rash occurs
  • Keep out of reach of child. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15min before sun exposure. Reapply after 80mins of swimming or sweating immediately after towel drying and at least every 2 hrs. For children under 6 months of age; ask a doctor.
  • 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun

Questions?

SPL UNCLASSIFIED SECTION

Contact support@babydonna.com

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caprylic Capric Triglycerides, Coconut Alkanes (and) Coco-Caprylate/Caprate Polyhydroxystearic Acid, Coco caprylate/caprate, Butyrospermum Parkii (Shea) Butter Copernicia Cerifera (Carnauba) Wax, Arachidyl Alcohol (and) Behenyl Alcohol (and) Arachidyl Glucoside Candelilla Wax (Euphorbia Cerifera), Cetearyl Alcohol 50, Hydrogenated Castor Oil, Glyceryl Caprylate Meadowfoam Seed Oil,Mixed Tocopherols (Vitamin E)

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83265-001-012025-01-30C16284748780-12cef2736-7983-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83265-001-01Baby Donna SHeer SPF Sunscreen Stick1 in 1 BOXSTICK11
83265-001-01Baby Donna SHeer SPF Sunscreen Stick16 g in 1 CONTAINERSTICK161

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83265-001BABY DONNA SHEER SPF SUNSCREEN STICK (ZINC OXIDE) STICK [BABYDONNA LLC]12 package rows20230301_af6b7f9f-9ca5-4c59-be78-d68286451ac3.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83265-00183265-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT ALKANES1E5KJY107TIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
CARNAUBA WAXR12CBM0EIZIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DOCOSANOL9G1OE216XYIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
CANDELILLA WAXWL0328HX19IACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
TOCOPHEROLR0ZB2556P8IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
SHEA BUTTERK49155WL9YIACT
ZINC OXIDESOI2LOH54ZACTIM

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
f5c83321-7832-9686-e053-2995a90a538eaf6b7f9f-9ca5-4c59-be78-d68286451ac32023-02-28WarningsExact identifier
spl id: f5c83321-7832-9686-e053-2995a90a538e
spl set id: af6b7f9f-9ca5-4c59-be78-d68286451ac3

Reported adverse events (FAERS/openFDA)#

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