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
2026-12-31

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 42 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.6a48ad0d-20e4-44b1-90d6-30bfbc68a1522026-04-17WarningsExact identifier
application number: M020
Pacto Refreshing Sunscreen Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEMynd LLC56ad7c97-3dae-4bac-a677-f5052dfdfea42026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f95cd0a-f996-648b-e063-6294a90adc282026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f968058-e851-86d0-e063-6294a90aa7862026-04-16WarningsExact identifier
application number: M020
Red Cherry SPF 15 Broad Spectrum Lip BalmRED CHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc4f96d057-39b8-e4d5-e063-6394a90acb5c2026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f970778-97d6-40a9-e063-6394a90a6c892026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-LightZINC OXIDEZO Skin Health, Inc.4f9988a0-ae4a-9940-e063-6294a90ad91d2026-04-16WarningsExact identifier
application number: M020
MELAO Hydrating Mineral SunscreenTITANIUM DIOXIDE,ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4f778eb0-55f7-38d0-e063-6394a90a69a02026-04-15WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC75820400-a5e0-4cf5-8b4f-a52500ce62c32026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f81e482-8111-451c-e063-6294a90ad1482026-04-15WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f8353b3-4ac1-9703-e063-6294a90abdad2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f83dd76-a8d8-916e-e063-6294a90ab6ed2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick - TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f84619f-3415-7443-e063-6394a90a162a2026-04-15WarningsExact identifier
application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDEPML NYC, LLC1be639a8-179a-7015-e063-6394a90ab64b2026-04-15WarningsExact identifier
application number: M020
PHELITYL DAY SPF 15PHELITYL DAY SPF 15PML NYC, LLCea9d33d9-6f9f-0a66-e053-2a95a90abd422026-04-15WarningsExact identifier
application number: M020
FIRMARINE MOISTURIZER SPF 30FIRMARINE MOISTURIZER SPF 30PML NYC, LLCea9db179-1b69-01e0-e053-2a95a90a16282026-04-15WarningsExact identifier
application number: M020
EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15PML NYC, LLCeaa562b1-3fc6-1a85-e053-2995a90ad1ec2026-04-15WarningsExact identifier
application number: M020
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30PML NYC, LLCea90bb4d-6f4a-45c9-e053-2a95a90a53a72026-04-15WarningsExact identifier
application number: M020
RICH GIRL HAND SPF 25RICH GIRL HANDPML NYC, LLCea8f4421-109f-41a5-e053-2a95a90a38322026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTERYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e24a63e-d76f-6581-e063-6394a90a61812026-04-15WarningsExact 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