FDA.reportPublic FDA data

SPF 50+ Sunscreen Lotion

Manufacturer
KAS Direct LLC dba BabyGanics
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:44:39

Label at a glance#

ProductSPF 50 plus Sunscreen
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
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50+
SPF

tear
free

water
resistant

babyganics

SPF 50+
sunscreen
lotion

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

formulated with: Zinc Oxide,
Octisalate, Titanium Dioxide*

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

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

6 FL OZ (177mL)

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label
PRINCIPAL DISPLAY PANEL - 177 mL Tube Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-1000-1SPF 50 plus Sunscreen354 mL in 1 TUBELOTION3542
59062-1000-2SPF 50 plus Sunscreen59 mL in 1 TUBELOTION592
59062-1000-6SPF 50 plus Sunscreen177 mL in 1 TUBELOTION1772
59062-1000-8SPF 50 plus Sunscreen236 mL in 1 TUBELOTION2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1000SPF 50 PLUS SUNSCREEN (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC, 4 package rows20241220_5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-100059062-1000-2, 59062-1000-6, 59062-1000-8, 59062-1000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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

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 SunscreenTITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDEKAS Direct LLC dba BabyGanics5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b2024-12-17WarningsExact identifier
ndc (package): 59062-1000-8
ndc (package): 59062-1000-1
ndc (package): 59062-1000-2
ndc (package): 59062-1000-6
ndc (product): 59062-1000
ndc11 (package): 59062100008
ndc11 (package): 59062100006
ndc11 (package): 59062100001
ndc11 (package): 59062100002
spl id: a7636b53-d9d4-4c4f-929a-515a8cc78659
spl set id: 5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b

Reported adverse events (FAERS/openFDA)#

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