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 52 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris UV Expert Aquagel Defense 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc500e58f-38b0-454e-8923-912844276b172026-03-20WarningsExact identifier
application number: M020
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZERTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED4a1ec566-549f-45f2-a43d-dacfc72633612026-03-20WarningsExact identifier
application number: M020
SOJO sunscreenZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d44efb6-abc5-c346-e063-6394a90a60232026-03-19WarningsExact identifier
application number: M020
VRC Lip balm SPF15ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d588fbe-e61a-2264-e063-6394a90aa0602026-03-19WarningsExact identifier
application number: M020
SOjO Lip balm SPF15ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d5ed865-fff2-ee44-e063-6294a90a67e22026-03-19WarningsExact identifier
application number: M020
ActivDerm Radiant Shield Broad Spectrum SPF 40ZINC OXIDEACTIVDERM LLC4d6307f1-bab6-5f44-e063-6294a90a8e362026-03-19WarningsExact identifier
application number: M020
Mad Robbit DEFEND SPF30SUNSCREENMAD RABBIT TATTOO, INC.bf853d54-ecd9-40cc-9f10-cb546bfb89332026-03-19WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREENZINC OXIDECLIO COSMETICS Co., Ltd.c7b13245-a3e0-4d53-b7fe-9b2c9707ab9e2026-03-18WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 BURNT MAPLEZINC OXIDECOSMAX USA4d318f51-1a43-44d5-e063-6394a90a49702026-03-17WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 HAZY MAUVEZINC OXIDECOSMAX USA4d319110-e6a4-1ad3-e063-6394a90aa99c2026-03-17WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORALZINC OXIDECOSMAX USA4d31b201-9d6a-730a-e063-6394a90a67002026-03-17WarningsExact identifier
application number: M020
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
application number: M020
Avobenzone, Homosalate, Octisalate, OctocryleneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4d3a36b9-7d63-01ac-e063-6294a90af4fb2026-03-17Warnings, Adverse reactionsExact identifier
application number: M020
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3a460b-1b98-2906-e063-6294a90a36692026-03-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30SKNVCARE, LLC4d3ad051-3729-06fd-e063-6394a90ad0fe2026-03-17WarningsExact 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