FDA.reportPublic FDA data

SPF 50 Mineral Sunscreen

Manufacturer
KAS Direct LLC dba BabyGanics | Autumn Harp
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:44:19

Label at a glance#

ProductSPF 50 Mineral Sunscreen Babyganics
Active ingredientTitanium Dioxide, ZINC OXIDE
Label structure11 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

Titanium dioxide 3%, Zinc oxide 12%

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, ethylhexyl palmitate, butyloctyl salicylate, caprylic/capric triglyceride, trimethylpentanediol/adipic acid/glycerin crosspolymer, cetearyl olivate, glycerin, sorbitan olivate, tocopheryl acetate, phenoxyethanol, cetearyl alcohol, cetearyl glucoside, propanediol, alumina, xanthan gum, jojoba esters, 1,2-hexanediol, bisabolol, helianthus annuus (sunflower) seed oil1, solanum lycopersicum (tomato) seed oil, lecithin, polyhydroxystearic acid, caprylhydroxamic acid, citric acid, isopropyl myristate, isostearic acid, polyglyceryl-3 polyricinoleate, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil

1 Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic • *Learn about these and all our ingredients and the choices we make at babyganics.com/products

SPL UNCLASSIFIED SECTION

dist. by KAS Direct, LLC
san francisco, ca 94111

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label - 59062-1001

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

non
allergenic

tear
free

babyganics®

SPF 50
mineral
sunscreen

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 the back panel.

2 FL OZ (59 mL)

Principal Display Panel - 59 mL Tube Label - 59062-1001
Principal Display Panel - 59 mL Tube Label - 59062-1001

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label - 59062-1101

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tear
free

kids
by babyganics®

easy rub-in

SPF 50
mineral
sunscreen

dermatologist tested

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

made without oxybenzone,
octinoxate, parabens, fragrance

Discover which of our ingredients are
certified organic on the back panel.

2 FL OZ (59 mL)

Principal Display Panel - 59 mL Tube Label - 59062-1101
Principal Display Panel - 59 mL Tube Label - 59062-1101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1001SPF 50 MINERAL SUNSCREEN BABYGANICS (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION SPF 50 MINERAL SUNSCREEN BKIDS (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]3Legacy NDC20241226_5453cd31-e70b-4f6c-81ce-206b960a54bc.zip
59062-1101SPF 50 MINERAL SUNSCREEN BABYGANICS (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION SPF 50 MINERAL SUNSCREEN BKIDS (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]3Legacy NDC20241226_5453cd31-e70b-4f6c-81ce-206b960a54bc.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-100159062-1001-2, 59062-1001-6, 59062-1001-8
59062-110159062-1101-2, 59062-1101-6

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 64 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
Ethylhexyl Palmitate2865993309IACT
Butyloctyl Salicylate2EH13UN8D3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)587WKM3S9QIACT
Cetearyl Olivate58B69Q84JOIACT
GLYCERINPDC6A3C0OXIACT
Sorbitan OlivateMDL271E3GRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Cetearyl Glucoside09FUA47KNAIACT
Propanediol5965N8W85TIACT
ALUMINUM OXIDELMI26O6933IACT
XANTHAN GUMTTV12P4NEEIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
1,2-HexanediolTR046Y3K1GIACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
SUNFLOWER OIL3W1JG795YIIACT
TOMATO SEED OIL7N87T9C06TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
Caprylhydroxamic AcidUPY805K99WIACT
Isopropyl Myristate0RE8K4LNJSIACT
Isostearic AcidX33R8U0062IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
CRANBERRY SEED OIL73KDS3BW5EIACT
Nigella Sativa Seed OilCS4U38E731IACT
RASPBERRY SEED OIL9S8867952AIACT
SOYBEAN LECITHIN1DI56QDM62IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
Titanium Dioxide15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
Ethylhexyl Palmitate2865993309IACT
Butyloctyl Salicylate2EH13UN8D3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)587WKM3S9QIACT
Cetearyl Olivate58B69Q84JOIACT

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
3f96c638-f7dc-47f1-8e14-894d033f75cf5453cd31-e70b-4f6c-81ce-206b960a54bc2024-12-23WarningsExact identifier
spl id: 3f96c638-f7dc-47f1-8e14-894d033f75cf
spl set id: 5453cd31-e70b-4f6c-81ce-206b960a54bc

Reported adverse events (FAERS/openFDA)#

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