FDA.reportPublic FDA data

Kids SPF 50 plus Sunscreen

Manufacturer
KAS Direct LLC dba BabyGanics
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:47:01

Label at a glance#

ProductSPF 50 plus Sunscreen All Mineral Active Ingredients
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 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 keep outer card for full drug facts

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7.9%, Zinc Oxide 6.7%

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
  • keep outer card for full drug facts

Inactive ingredients

INACTIVE INGREDIENT SECTION

C12-15 alkyl benzoate, caprylic/capric triglyceride, beeswax1, copernicia cerifera (carnauba) wax1, neopentyl glycol diethylhexanoate, tribehenin, euphorbia cerifera (candelilla) wax, PPG-3 benzyl ether myristate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, helianthus annuus (sunflower) seed wax, myristyl myristate, stearyl/octadodecyl citrate crosspolymer, simmondsia chinensis (jojoba) seed oil1, polyglyceryl-10 pentaoleate, jojoba esters, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (raspberry) seed oil, polyhydroxystearic acid, caprylyl glycol, ethylhexylglycerin, silica, alumina

1 Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic

SPL UNCLASSIFIED SECTION

dist. by KAS direct, LLC
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - 13 g Applicator Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

babyganics®

SPF 50 mineral sunscreen

broad spectrum SPF 50

pediatrician
&
dermatologist
tested

water
resistant
(80 minutes)

Discover which of
our ingredients are
Certified Organic
on back panel.

NET WT 0.47 OZ (13 g)

Principal Display Panel - 13 g Applicator Blister Pack
Principal Display Panel - 13 g Applicator Blister Pack

PRINCIPAL DISPLAY PANEL - 45.5 g Applicator Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50+
SPF

babyganics

kids

SPF 50+ sunscreen stick
all mineral active ingredients

broad spectrum SPF 50+
UVA + UVB protection
non-allergenic • water &
sweat resistant (80 minutes)
tear free • pediatrician &
dermatologist tested

formulated with: Titanium
Dioxide, Zinc Oxide*

formulated without: PABA
phthalates • parabens
fragrances • nano-particles

Discover which of our
ingredients are Certified
Organic on back panel.

Net. Wt. 1.6 OZ (45.5 g)

040-17936-B01

Principal Display Panel - 45.5 g Applicator Label
Principal Display Panel - 45.5 g Applicator Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-1200-1SPF 50 plus Sunscreen All Mineral Active Ingredients13 g in 1 APPLICATORSTICK133
59062-1200-1SPF 50 plus Sunscreen All Mineral Active Ingredients1 in 1 BLISTER PACKSTICK13
59062-1200-2SPF 50 plus Sunscreen All Mineral Active Ingredients2 in 1 BLISTER PACKSTICK23
59062-1200-2SPF 50 plus Sunscreen All Mineral Active Ingredients13 g in 1 APPLICATORSTICK133
59062-2200-4Kids SPF 50 plus Sunscreen All Mineral Active Ingredients45.5 g in 1 APPLICATORSTICK45.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1200SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS (TITANIUM DIOXIDE AND ZINC OXIDE) STICK KIDS SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [KAS DIRECT LLC DBA BABYGANICS]3Current NDC, Legacy NDC, 4 package rows20241222_247aae3d-1845-4dd8-b774-b9e8214809a2.zip
59062-2200SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS (TITANIUM DIOXIDE AND ZINC OXIDE) STICK KIDS SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [KAS DIRECT LLC DBA BABYGANICS]3Legacy NDC, 1 package rows20241222_247aae3d-1845-4dd8-b774-b9e8214809a2.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-120059062-1200-1, 59062-1200-2
59062-220059062-2200-4

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
TRIBEHENIN8OC9U7TQZ0IACT
CANDELILLA WAXWL0328HX19IACT
PPG-3 BENZYL ETHER MYRISTATE8075L58MKOIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
Stearyl/Octyldodecyl Citrate CrosspolymerPN88NW0KPKIACT
JOJOBA OIL724GKU717MIACT
Polyglyceryl-10 PentaoleateBH1TF96DJCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
RASPBERRY SEED OIL9S8867952AIACT
CRANBERRY SEED OIL73KDS3BW5EIACT
SUNFLOWER OIL3W1JG795YIIACT
TOMATO SEED OIL7N87T9C06TIACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
Silicon DioxideETJ7Z6XBU4IACT
Aluminum OxideLMI26O6933IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
TRIBEHENIN8OC9U7TQZ0IACT
CANDELILLA WAXWL0328HX19IACT
PPG-3 BENZYL ETHER MYRISTATE8075L58MKOIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
Stearyl/Octyldodecyl Citrate CrosspolymerPN88NW0KPKIACT
JOJOBA OIL724GKU717MIACT

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 plus Sunscreen All Mineral Active IngredientsTITANIUM DIOXIDE AND ZINC OXIDEKAS Direct LLC dba BabyGanics247aae3d-1845-4dd8-b774-b9e8214809a22024-12-18WarningsExact identifier
ndc (package): 59062-1200-1
ndc (package): 59062-1200-2
ndc (package): 59062-2200-4
ndc (product): 59062-1200
ndc (product): 59062-2200
ndc11 (package): 59062220004
ndc11 (package): 59062120001
ndc11 (package): 59062120002
spl id: d1f4c797-2359-448a-8112-f69f227f475d
spl set id: 247aae3d-1845-4dd8-b774-b9e8214809a2

Reported adverse events (FAERS/openFDA)#

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