FDA.reportPublic FDA data

Babyganics Sheer Blend SPF50 Mineral Sunscreen

Manufacturer
KAS Direct LLC dba BabyGanics | APEX International MFG., LLC | Voyant Beauty, Inc.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:48:02

Label at a glance#

ProductBabyganics Sheer Blend SPF50 Mineral Sunscreen
Active ingredientZinc 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

Zinc oxide 20%

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

butyloctyl salicylate, butyrospermum parkii (shea) butter1, caprylic/capric triglyceride, capryloyl glycine, caprylyl glycol, coco-caprylate, cocos nucifera (coconut) oil1, ethylhexylglycerin, glycerin1, helianthus annuus (sunflower) seed oil1, lsoamyl laurate, magnesium stearate, magnesium sulfate, nigella sativa seed oil1, polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyhydroxystearic acid, propanediol, rubus ldaeus (raspberry) seed oil, sodium phytate, solanum lycopersicum (tomato) seed oil, stearyl/octyldodecyl citrate crosspolymer, undecylenoyl glycine, vaccinium macrocarpon (cranberry) seed oil, water

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 236 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

non
allergenic

blends in
& blocks
out

babyganics®

SHEER BLEND

SPF 50 mineral
sunscreen

fragrance free

tear free • pediatrician tested

broad spectrum SPF 50
water resistant (80 minutes)

made without oxybenzone, octinoxate,
parabens, fragrance, nano-particles

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

8 FL OZ (236 mL)

PRINCIPAL DISPLAY PANEL - 236 mL Tube Label
PRINCIPAL DISPLAY PANEL - 236 mL Tube Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-2202-1Babyganics Sheer Blend SPF50 Mineral Sunscreen50 mL in 1 TUBELOTION503
59062-2202-3Babyganics Sheer Blend SPF50 Mineral Sunscreen89 mL in 1 TUBELOTION893
59062-2202-8Babyganics Sheer Blend SPF50 Mineral Sunscreen236 mL in 1 TUBELOTION2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-2202BABYGANICS SHEER BLEND SPF50 MINERAL SUNSCREEN (ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]3Current NDC, 3 package rows20241222_edced0dc-dd43-4ac9-b816-f4edb45fc87b.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-220259062-2202-8, 59062-2202-3, 59062-2202-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Coco-Caprylate4828G836N6IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
Isoamyl laurateM1SLX00M3MIACT
MAGNESIUM STEARATE70097M6I30IACT
Shea Butter Ethyl EstersV2CI786FPGIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Polyglyceryl-2 oleate5759J47SAMIACT
Polyglyceryl-2 stearate253MC0P0YVIACT
Propanediol5965N8W85TIACT
Stearyl/Octyldodecyl Citrate CrosspolymerPN88NW0KPKIACT
Undecylenoyl Glycine4D20464K2JIACT
Ethylhexylglycerin147D247K3PIACT
GlycerinPDC6A3C0OXIACT
PHYTATE SODIUM88496G1ERLIACT
SUNFLOWER SEEDR9N3379M4ZIACT
TOMATO SEED OIL7N87T9C06TIACT
CRANBERRY SEED38ZFO1X2U7IACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
Capryloyl Glycine8TY5YO42NJIACT
Caprylyl Glycol00YIU5438UIACT

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
Babyganics Sheer Blend SPF50 Mineral SunscreenZINC OXIDEKAS Direct LLC dba BabyGanicsedced0dc-dd43-4ac9-b816-f4edb45fc87b2024-12-20WarningsExact identifier
ndc (package): 59062-2202-1
ndc (package): 59062-2202-3
ndc (package): 59062-2202-8
ndc (product): 59062-2202
ndc11 (package): 59062220201
ndc11 (package): 59062220208
ndc11 (package): 59062220203
spl id: 24088d16-eb60-456f-bae3-a48db5a5d878
spl set id: edced0dc-dd43-4ac9-b816-f4edb45fc87b

Reported adverse events (FAERS/openFDA)#

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