FDA.reportPublic FDA data

babyganics® Sunscreen Lotion 30SPF

Manufacturer
KAS Direct LLC dba BabyGanics
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:44:31

Label at a glance#

ProductBabyGanics Sunscreen 30SPF
Active ingredientTITANIUM DIOXIDE, 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 40 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 3.0%, Zinc oxide 3.0%

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 40 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, cetearyl olivate, cocos nucifera (coconut) oil, sorbitan olivate, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl alcohol, stearyl/octadodecyl citrate crosspolymer, glycerin, ozokerite, simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, jojoba esters, squalane, glyceryl caprylate, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, sucrose stearate, stearic acid, polyglyceryl-2 caprate, xanthan gum, polyhydroxystearic acid, silica, alumina, trisodium ethylenediamine disuccinate, ethylhexylglycerin, phenoxyethanol

SPL UNCLASSIFIED SECTION

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30
SPF

tear
free

water
resistant

babyganics®

pure mineral
sunscreen

broad spectrum SPF 30
UVA + UVB protection
water resistant
(40 minutes)
non-allergenic

no: chemical sunscreen,
PABA, phthalates, parabens,
fragrances or nano-particles

4 FL OZ (118mL)

Principal Display Panel - 118 mL Tube Label
Principal Display Panel - 118 mL Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59062-1227-12020-02-04C16284748780-19d75b9d0-9517-f424-e053-dadaa90a57cebabyganics® Sunscreen Lotion 30SPF
59062-1227-12020-01-31C16284748780-19d75b9d0-9517-f424-e053-dadaa90a57cebabyganics® Sunscreen Lotion 30SPF

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69332
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BU2
ARACHIDYL GLUCOSIDEINACTIVE INGREDIENT6JVW35JOOJ2
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D32
CERESININACTIVE INGREDIENTQ1LS2UJO3A2
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JO2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L2
DECYL JOJOBATEINACTIVE INGREDIENTZL61O8TFZU2
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL CAPRYLATEINACTIVE INGREDIENTTM2TZD4G4A2
JOJOBA OILINACTIVE INGREDIENT724GKU717M2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
MONOSTEARYL CITRATEINACTIVE INGREDIENTYWW937R1QR2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F2
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GR2
SQUALANEINACTIVE INGREDIENTGW89575KF92
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50M2
TRISODIUM ETHYLENEDIAMINE DISUCCINATEINACTIVE INGREDIENTYA22H34H9Q2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

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
59062-122759062-1227-1

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
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETEARYL OLIVATE58B69Q84JOIACT
COCONUT OILQ9L0O73W7LIACT
SORBITAN OLIVATEMDL271E3GRIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
CETYL ALCOHOL936JST6JCNIACT
MONOSTEARYL CITRATEYWW937R1QRIACT
GLYCERINPDC6A3C0OXIACT
CERESINQ1LS2UJO3AIACT
JOJOBA OIL724GKU717MIACT
SHEA BUTTERK49155WL9YIACT
COCOA BUTTER512OYT1CRRIACT
DECYL JOJOBATEZL61O8TFZUIACT
SQUALANEGW89575KF9IACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DOCOSANOL9G1OE216XYIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
SUCROSE STEARATE274KW0O50MIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM OXIDELMI26O6933IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 250 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
SUCROSE STEARATESUCROSE STEARATE274KW0O50MCAPSULE, EXTENDED RELEASE / ORAL57 mgExact identifier — unii candidate
4 equally ranked IID candidates
COCOA BUTTERCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CERESINCERESINQ1LS2UJO3AOINTMENT / TOPICAL1097 mgExact identifier — unii candidate
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
DOCOSANOLDOCOSANOL9G1OE216XYSOLUTION / TOPICAL1.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
SUCROSE STEARATESUCROSE STEARATE274KW0O50MTABLET, FILM COATED / ORAL65 mgExact identifier — unii candidate
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates

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
abd16c6e-7dd7-467c-ade3-91498ca71e370da5c6ee-91d9-41c8-90c2-93b096b6d55b2024-12-18WarningsExact identifier
spl id: abd16c6e-7dd7-467c-ade3-91498ca71e37
spl set id: 0da5c6ee-91d9-41c8-90c2-93b096b6d55b

Reported adverse events (FAERS/openFDA)#

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