FDA.reportPublic FDA data

Kids SPF50+ Mineral Sunscreen Spray Continuous Totally Tropical

Manufacturer
KAS Direct LLC dba BabyGanics | Fruit of the Earth, Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:48:44

Label at a glance#

ProductKids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical
Active ingredientZinc Oxide, Titanium Dioxide
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

shake well before each use hold can 4-6 inches away from the skin to apply spray liberally and spread evenly by hand 15 minutes before sun exposure do not spray directly into face. Spray on hands then apply to face. do not apply in windy conditions use in a well-ventilated area reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: as...

Storage and handling

protect this product from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 3.5%, Zinc oxide 7.25%

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

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.
  • keep away from face to avoid breathing it
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

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

  • shake well before each use
  • hold can 4-6 inches away from the skin to apply
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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
  • may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, isododecane, caprylic/capric triglyceride, isohexadecane, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, shea butter ethyl esters, carthamus tinctorius (safflower) seed oil, C30-38 olefin/isopropyl maleate/MA copolymer, butyloctyl salicylate, coco-glucoside, cetearyl alcohol, cetearyl glucoside, cetearyl olivate, sorbitan olivate, ethylhexylglycerin, simmondsia chinensis (jojoba) seed oil1, sodium hydroxide, chlorphenesin, xanthan gum, tocopherol, glycerin1, sodium phytate, helianthus annuus (sunflower) seed oil1, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (raspberry) seed oil, citric acid, fragrance2

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

2 Product formulated with plant-derived fragrance and ingredients chosen with kids in mind. Learn about these and all our ingredients and the choices we make at babyganics.com/products

SPL UNCLASSIFIED SECTION

Dist. by KAS Direct, LLC
1525 Howe St., Racine, WI 53403

PRINCIPAL DISPLAY PANEL - 170 g Can Blister Pack Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

twin pack

tear
free

kids
by babyganics®

easy rub-in

SPF 50
mineral
sunscreen
totally tropical

dermatologist tested

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

made without oxybenzone, octinoxate, parabens

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

2 - NET WT 6 OZ (170 g) each

Principal Display Panel - 170 g Can Blister Pack Label
Principal Display Panel - 170 g Can Blister Pack Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-2400-2Kids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical2 in 1 BLISTER PACKSPRAY24
59062-2400-6Kids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical170 g in 1 CANSPRAY1704

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-2400KIDS SPF50 PLUS MINERAL SUNSCREEN CONTINUOUS TOTALLY TROPICAL (ZINC OXIDE AND TITANIUM DIOXIDE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]4Current NDC, Legacy NDC, 2 package rows20241226_d5ffe993-de8f-4623-a010-9cb8dd70de07.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-240059062-2400-6, 59062-2400-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
IsododecaneA8289P68Y2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Isohexadecane918X1OUF1EIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
Neopentyl Glycol Diheptanoate5LKW3C543XIACT
Shea Butter Ethyl EstersV2CI786FPGIACT
SAFFLOWER OIL65UEH262ISIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
Butyloctyl Salicylate2EH13UN8D3IACT
COCO-GLUCOSIDEICS790225BIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Cetearyl Glucoside09FUA47KNAIACT
Cetearyl Olivate58B69Q84JOIACT
Sorbitan OlivateMDL271E3GRIACT
Ethylhexylglycerin147D247K3PIACT
JOJOBA OIL724GKU717MIACT
Sodium Hydroxide55X04QC32IIACT
ChlorphenesinI670DAL4SZIACT
Xanthan GumTTV12P4NEEIACT
TocopherolR0ZB2556P8IACT
GlycerinPDC6A3C0OXIACT
PHYTATE SODIUM88496G1ERLIACT
SUNFLOWER SEEDR9N3379M4ZIACT
TOMATO SEED OIL7N87T9C06TIACT
CRANBERRY SEED38ZFO1X2U7IACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
Kids SPF50 Plus Mineral Sunscreen Continuous Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd5ffe993-de8f-4623-a010-9cb8dd70de072024-12-23WarningsExact identifier
ndc (package): 59062-2400-6
ndc (package): 59062-2400-2
ndc (product): 59062-2400
ndc11 (package): 59062240006
ndc11 (package): 59062240002
spl id: d0063c7f-fb51-4d93-b9e2-d30d8290b1f2
spl set id: d5ffe993-de8f-4623-a010-9cb8dd70de07

Reported adverse events (FAERS/openFDA)#

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