FDA.reportPublic FDA data

THINKBABY

Product NDC
60781-1003
Requested package NDC
60781-1003-6
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
2026-12-31
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 1 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm DuskSPF50Grace And Fire USA Inc.2735ab0f-5eec-04c5-e063-6394a90aa60e2026-10-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm BejewelledSPF50Grace And Fire USA Inc.274a0544-6c71-4d91-e063-6394a90a22472026-10-01WarningsExact identifier
application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENETrilipid Research Institute, LLC7f34de0a-eeb3-4b71-9abd-53d03266d9932026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC6a43173f-41f9-4207-a0db-53bc8db6f4a42026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd69b4992-d7e6-4bd7-b144-0485e35818a62026-09-10WarningsExact identifier
application number: M020
Hydra Finish SPF 15HOMOSALATE, OCTINOXATEGuinot4047e8ec-834a-41e6-a144-5649a7718de42026-09-10WarningsExact identifier
application number: M020
HYDRA BEAUTE SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot806d1e18-a3fc-43df-a52a-a640902d08872026-09-10WarningsExact identifier
application number: M020
Pur Confort SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot2fe0656f-f924-48da-91bf-d6f3d98e8fd92026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC51f3d6ca-3189-4380-9afb-4259ba8782742026-09-10WarningsExact identifier
application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinotb0a95379-998a-4cda-bae7-63faf3d6f3c82026-09-10WarningsExact identifier
application number: M020
Sun Logic Lait Solaire Corps SPF 20AVOBENZONE, HOMOSALATE, OCTOCRYLENEGuinotd9d2cee0-9189-42d0-b1ab-78b97141b1282026-09-10WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 301226 W AESTHETICS5b0ef395-a7dd-378e-e063-6394a90a5dce2026-09-09WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
application number: M020
Baloom 2% Panthenol Hydro Airy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENEARSN KOREA5148b638-f8a4-fa8b-e063-6294a90ac2082026-09-08WarningsExact identifier
application number: M020
Double-Duty Face MoisturizerMOSITURIZING SUNSCREENJack Black, LLC672be406-e3a1-47b4-8ef6-ee2b62baae962026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
application number: M020

Packages#

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