FDA.reportPublic FDA data

outdoor essentials

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 23:44:23

Label at a glance#

Productoutdoor essentials
Active ingredientZINC OXIDE, OCTISALATE, OCTOCRYLENE
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 do not spray directly into face. Spray on hands then apply to face. 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 sunscre...

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 11.20%, Octocrylene 6.0%, Octisalate 5.0%

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
    • do not spray directly into face. Spray on hands then apply to face.
  • 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, caprylic/capric triglyceride, glycerin, butyloctyl salicylate, stearyl/octyldodecyl citrate crosspolymer, aloe barbadensis leaf juice, glyceryl stearate, polyglyceryl-6 polyricinoleate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, lecithin, polysorbate 60, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil organic, rubus idaeus (raspberry) seed oil, squalane, xanthan gum, polysorbate 80, phenethyl alcohol, glyceryl caprylate, lithium magnesium sodium silicate, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, sorbitan isostearate, citric acid

SPL UNCLASSIFIED SECTION

dist. by KAS direct, LLC
San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

outdoor essentials

babyganics

SPF 50+
sunscreen spray
broad spectrum SPF 50+
UVA + UVB protection ∙ non-allergenic
water resistant (80 minutes)

natural
insect repellent
plant and essential oils help keep
mosquitoes away

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

6 FL OZ (177 mL)
6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

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
59062-5400-12022-07-29C16284748780-1e4f33bdf-a72d-d8a0-e053-dadaa90a6e4eoutdoor essentials

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-0120-6outdoor essentials177 mL in 1 BOTTLE, SPRAYSPRAY177 mL112 mg in 1mL2
59062-5400-1outdoor essentials1 in 1 PACKAGEKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-0120OUTDOOR ESSENTIALS (ZINC OXIDE, OCTOCRYLENE, AND OCTISALATE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC20211023_93ef5b1b-e4f4-4c86-a395-c19861866c3e.zip
59062-5400OUTDOOR ESSENTIALS (ZINC OXIDE, OCTOCRYLENE, AND OCTISALATE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Legacy NDC, 2 package rows20211023_93ef5b1b-e4f4-4c86-a395-c19861866c3e.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-540059062-5400-1
59062-012059062-0120-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
POLYSORBATE 806OZP39ZG8HIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
LAPONITED703131383IACT
XANTHAN GUMTTV12P4NEEIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SQUALANEGW89575KF9IACT
TOMATO SEED OIL7N87T9C06TIACT
SUNFLOWER OIL3W1JG795YIIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYSORBATE 60CAL22UVI4MIACT
ALOE VERA LEAFZY81Z83H0XIACT
CRANBERRY SEED OIL73KDS3BW5EIACT
RASPBERRY SEED OIL9S8867952AIACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SOYBEAN OIL241ATL177AINGR
ROSEMARY OIL8LGU7VM393INGR
CITRONELLA OILQYO8Q067D0INGR
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGINGR
JUNIPERUS VIRGINIANA OILPAD4FN7P2GINGR
PEPPERMINT OILAV092KU4JHINGR
WEST INDIAN LEMONGRASS OIL5BIA40E9EDINGR

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
BABYGANICS SPF 50 Plus SUNSCREENZINC OXIDE, OCTISALATE, AND OCTOCRYLENEKAS Direct LLC dba Babyganics4075f9dc-c25f-434f-a3fc-a7f896295c3d2024-12-20WarningsExact identifier
ndc (product): 59062-0120
642b8cd3-e9ca-415b-b473-effd047e494c93ef5b1b-e4f4-4c86-a395-c19861866c3e2021-07-19WarningsExact identifier
spl id: 642b8cd3-e9ca-415b-b473-effd047e494c
spl set id: 93ef5b1b-e4f4-4c86-a395-c19861866c3e

Reported adverse events (FAERS/openFDA)#

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