FDA.reportPublic FDA data

SPF 50 Mineral Sunscreen

Manufacturer
KAS Direct LLC dba BabyGanics
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:20:29

Label at a glance#

ProductSPF 50 Mineral Sunscreen bkids
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 and evenly 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours this product is meant for targeted protection and small areas of exposed skin for full protection use in conjunction with another sunscreen lotion or spray children under 6 months of age: ask a doctor Sun Protection Measures. Spending time in the sun incr...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 21.6%

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • this product is meant for targeted protection and small areas of exposed skin
  • for full protection use in conjunction with another sunscreen lotion or spray
  • 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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

isopropyl palmitate, ozokerite, cetyl alcohol, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, butyloctyl salicylate, silica, beeswax, isostearic acid, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, caprylyl glycol, centella asiatica (gotu kola) extract, daucus carota stavia (carrot) seed oil, euphorbia cerifera (candelilla) wax, polyhydroxystearic acid, rubus idaeus (raspberry) seed oil

1 Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic. • *Learn about these and all our ingredients and the choices we make at babyganics.com/products

SPL UNCLASSIFIED SECTION

dist. by KAS
Direct, LLC
san francisco, ca
94111

PRINCIPAL DISPLAY PANEL - 45 g Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tear
free

kids
by babyganics®

easy rub-in

SPF 50
mineral sunscreen

dermatologist tested

broad spectrum SPF 50
water & sweat resistant (80 minutes)

Discover which of our ingredients are certified
organic inside the back label.

1118956
NET WT 1.6 OZ (45 g)

PRINCIPAL DISPLAY PANEL - 45 g Container Label
PRINCIPAL DISPLAY PANEL - 45 g Container Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-2201-4SPF 50 Mineral Sunscreen bkids45 g in 1 CONTAINERSTICK454

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-220159062-2201-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
YELLOW WAX2ZA36H0S2VIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CENTELLA ASIATICA WHOLE7M867G6T1UIACT
CETYL ALCOHOL936JST6JCNIACT
CARROT SEED OIL595AO13F11IACT
CANDELILLA WAXWL0328HX19IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ISOSTEARIC ACIDX33R8U0062IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
CERESINQ1LS2UJO3AIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
RASPBERRY SEED OIL9S8867952AIACT
CRANBERRY SEED OIL73KDS3BW5EIACT
SUNFLOWER OIL3W1JG795YIIACT
Water059QF0KO0RIACT
TOMATO SEED OIL7N87T9C06TIACT

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
SPF 50 Mineral Sunscreen bkidsZINC OXIDEKAS Direct LLC dba BabyGanicsf717cd89-194b-42e3-a079-24b2903deb292025-12-05WarningsExact identifier
ndc (package): 59062-2201-4
ndc (product): 59062-2201
ndc11 (package): 59062220104
spl id: dc9ac864-32ee-4bc1-948f-da5c962bb422
spl set id: f717cd89-194b-42e3-a079-24b2903deb29

Reported adverse events (FAERS/openFDA)#

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