outdoor explorer set

Manufacturer
KAS Direct LLC dba BabyGanics
Effective date
2021-07-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:34

Label at a glance#

Productoutdoor explorer set
Active ingredientTitanium Dioxide, OCTISALATE, ZINC 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 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

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

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

PRINCIPAL DISPLAY PANEL - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bites? burns?
we've got you
covered

babyganics

outdoor
explorer
set

natural
insect repellent

6 FL OZ (177 mL)

SPF 50+
sunscreen lotion

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

2 FL OZ (59 mL)

Principal Display Panel - Kit Package
Principal Display Panel - Kit Package

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59062-5300-12022-07-29C16284748780-1e4f33bdf-a347-d8a0-e053-dadaa90a6e4eoutdoor explorer set

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-1000-2outdoor explorer set59 mL in 1 TUBELOTION59 mL50 mg in 1mL2
59062-5300-1outdoor explorer set1 in 1 PACKAGEKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1000OUTDOOR EXPLORER SET (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC20210720_726096c2-514a-439a-9697-346ca684c493.zip
59062-5300OUTDOOR EXPLORER SET (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Legacy NDC, 2 package rows20210720_726096c2-514a-439a-9697-346ca684c493.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-530059062-5300-1
59062-100059062-1000-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 50 plus SunscreenTITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDEKAS Direct LLC dba BabyGanics5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b2024-12-17WarningsExact identifier
ndc (package): 59062-1000-2
ndc (product): 59062-1000
ndc11 (package): 59062100002
132c4b8e-b4f3-478d-b6eb-f4496726f568726096c2-514a-439a-9697-346ca684c4932021-07-19WarningsExact identifier
spl id: 132c4b8e-b4f3-478d-b6eb-f4496726f568
spl set id: 726096c2-514a-439a-9697-346ca684c493

Reported adverse events (FAERS/openFDA)#

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