FDA.reportPublic FDA data

THINKBABY

Product NDC
60781-1003
11-digit product format
607811003
Labeler code
60781
Product ID
60781-1003_e256956f-d969-4a13-8cd9-93461ba5a816
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
thinkOperations,LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-14
Substance
ZINC OXIDE
Active strength
200 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
THINKBABY
Brand name suffix
Baby Sunscreen SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
820317d2-1803-4949-bddf-09521a5d1750Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60781-1003-3THINKBABY Baby Sunscreen SPF 5089 mL in 1 TUBELOTION896
60781-1003-6THINKBABY Baby Sunscreen SPF 50177 mL in 1 TUBELOTION1776

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
zinc oxideACTIVE INGREDIENTSOI2LOH54ZTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
zinc oxideACTIVE MOIETYSOI2LOH54ZTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
CETYL DIMETHICONE 25INACTIVE INGREDIENTU4AS1BW4ZBTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
CRANBERRY SEED OILINACTIVE INGREDIENT73KDS3BW5ETHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQYTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1ETHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
PAPAYAINACTIVE INGREDIENTKU94FIY6JBTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
PINUS MUGO SUBSP. MUGO BARKINACTIVE INGREDIENTSBJ2CP47EETHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
RASPBERRY SEED OILINACTIVE INGREDIENT9S8867952ATHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YITHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8THINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
TRICAPRININACTIVE INGREDIENTO1PB8EU98MTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTHINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60781-1003THINKBABY BABY SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [THINKOPERATIONS,LLC]6Current NDC, Legacy NDC, 2 package rows20231213_820317d2-1803-4949-bddf-09521a5d1750.zip

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 64 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6d1ad14e-afc6-4676-87d7-3e50e3a02fe92026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Babies SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC64766ed9-bd47-498d-bf59-fb30a7bf7e892026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCccb651f6-e567-4c5f-9109-8767270cc4be2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC80dcd255-3a6c-4b79-b081-519c9dac990a2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Service, LLC9de8b6b1-024b-4b71-96e6-fea68088d3ab2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenSUNSCREENRetail Business Services, LLC96221c10-ebfe-4385-b6b5-d504258df36c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCe2adbde9-3c8b-45f3-b4ef-4936b88d812d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Sunkissed GlowZINC OXIDE SUNSCREENBentley Laboratories, LLCbf1a237b-b27e-4c55-8ded-e348240a5b9a2026-02-06WarningsExact identifier
application number: M020
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
application number: M020
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
application number: M020
Sun Veil IlluminatingElixir Face Sunscreen SPF 38OCTISALATE, OCTOCRYLENE, ZINC OXIDEKoco Life LLC4a15c479-d676-9e52-e063-6394a90a4eb42026-02-05WarningsExact identifier
application number: M020
Golden Sunglaze Sheer Body Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC22d0a5db-6af1-a3ca-e063-6394a90a68ef2026-02-05WarningsExact identifier
application number: M020
Sunglaze Sheer Setting Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTYOCRYLENEKoco Life LLC22ce9b26-2bf8-c1ea-e063-6394a90a8ec22026-02-05WarningsExact identifier
application number: M020
Peppermint SPF 15 Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.24adffd4-5177-f5d5-e063-6294a90a78502026-02-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
application number: M020
Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited66f29201-6cbe-46d0-b54c-005a1ecefac42026-02-04WarningsExact identifier
application number: M020
Tanning Club Mineral Sunscreen SPF 30ZINC OXIDETanning Club LLCd674ccbc-7bae-435c-a531-a79e569e69a92026-02-04WarningsExact identifier
application number: M020
Derma B Everyday Fit Sunscreen SPF 50AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeoPharm Co., Ltd.ba38a43d-7a8a-4814-ba34-0e99124f5fca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION42adc51f-f500-485d-82a0-1266721412622026-02-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60781-1003-36078110030389 mL in 1 TUBE (60781-1003-3) 89 ml2013-08-140000-00-00NoNoCurrent
60781-1003-660781100306177 mL in 1 TUBE (60781-1003-6) 177 ml2013-08-140000-00-00NoNoCurrent