FDA.reportPublic FDA data

suncare essentials

Manufacturer
KAS Direct LLC dba BabyGanics
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:43:40

Label at a glance#

Productsuncare essentials
Active ingredientTitanium Dioxide, OCTISALATE, ZINC OXIDE
Label structure18 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 reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 pro...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SPF 50+ sunscreen lotion

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5.0%, Titanium Dioxide 3.0%, Zinc Oxide 6.0%

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 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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

water, butyloctyl salicylate, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, stearyl/octyldodecyl citrate crosspolymer, polyglyceryl-2 stearate, simmondsia chinensis (jojoba) seed oil1, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, glyceryl stearate, cetyl alcohol, cocos nucifera (coconut) oil1, glycerin1, 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, butyrospermum parkii (shea) butter1, jojoba esters, stearyl alcohol, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, polyhydroxystearic acid, xanthan gum, silica, alumina, ethylhexylglycerin, trisodium ethylenediamine disuccinate, phenoxyethanol

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

SPL UNCLASSIFIED SECTION

SPF 50+ sunscreen stick

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 of 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 card for full drug facts

Inactive ingredients

INACTIVE INGREDIENT SECTION

C12-15 alkyl benzoate, caprylic/capric triglyceride, beeswax2, copernicia cerifera (carnauba) wax2, 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 oil2, polyglyceryl-10 pentaoleate, jojoba esters, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil2, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil2, rubus idaeus (raspberry) seed oil, polyhydroxystearic acid, caprylyl glycol, ethylhexylglycerin, silica, alumina

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

SPL UNCLASSIFIED SECTION

dist. by KAS direct, LLC
1600 Stewart Avenue
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

babyganics

suncare essentials
SPF 50+

we've got
you covered
from head
to toe!

SPF 50+ sunscreen lotion
6 FL OZ (177mL)

SPF 50+
sunscreen stick
Net wt 0.47 OZ (13 g)

PRINCIPAL DISPLAY PANEL - Kit Package
PRINCIPAL DISPLAY PANEL - Kit Package

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1000SUNCARE ESSENTIALS (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC20250104_96fd2cf8-cb07-4ec1-8946-8e862f6d8377.zip
59062-1200SUNCARE ESSENTIALS (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC20250104_96fd2cf8-cb07-4ec1-8946-8e862f6d8377.zip
59062-5100SUNCARE ESSENTIALS (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Legacy NDC20250104_96fd2cf8-cb07-4ec1-8946-8e862f6d8377.zip

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-510059062-5100-1
59062-100059062-1000-6
59062-120059062-1200-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 58 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Neopentyl Glycol DiethylhexanoateU68ZV6W62CIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Stearyl/Octyldodecyl Citrate CrosspolymerPN88NW0KPKIACT
Polyglyceryl-2 Stearate253MC0P0YVIACT
CETYL ALCOHOL936JST6JCNIACT
JOJOBA OIL724GKU717MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
COCONUT OILQ9L0O73W7LIACT
TOMATO SEED OIL7N87T9C06TIACT
SUNFLOWER OIL3W1JG795YIIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CRANBERRY SEED OIL73KDS3BW5EIACT
Nigella Sativa Seed OilCS4U38E731IACT
RASPBERRY SEED OIL9S8867952AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
Stearyl Alcohol2KR89I4H1YIACT
Arachidyl Alcohol1QR1QRA9BUIACT
Arachidyl Glucoside6JVW35JOOJIACT
DOCOSANOL9G1OE216XYIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM OXIDELMI26O6933IACT
Trisodium Ethylenediamine DisuccinateYA22H34H9QIACT
Titanium Dioxide15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
TRIBEHENIN8OC9U7TQZ0IACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
db3f4cdd-aa6d-4454-b38a-24b8173a974396fd2cf8-cb07-4ec1-8946-8e862f6d83772024-12-26WarningsExact identifier
spl id: db3f4cdd-aa6d-4454-b38a-24b8173a9743
spl set id: 96fd2cf8-cb07-4ec1-8946-8e862f6d8377
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 (product): 59062-1200
ndc11 (package): 59062120001
SPF 50 plus SunscreenTITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDEKAS Direct LLC dba BabyGanics5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b2024-12-17WarningsExact identifier
ndc (package): 59062-1000-6
ndc (product): 59062-1000
ndc11 (package): 59062100006

Reported adverse events (FAERS/openFDA)#

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