FDA.reportPublic FDA data

Baby Diaper Rash Cream

Product NDC
71630-549
11-digit product format
716300549
Labeler code
71630
Product ID
71630-549_2ccb71b9-14a3-ffee-e063-6294a90a8285
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
doTERRA International, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-09
Substance
ZINC OXIDE
Active strength
25 g/100g
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
Baby Diaper Rash Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1125471Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
641465a1-0daf-1bb9-e053-2a91aa0ab25dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-01-31Baby Diaper Rash Cream
2022-01-28Baby Diaper Rash Cream
2020-02-03Baby Diaper Rash Cream
2020-01-31Baby Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71630-549-60Baby Diaper Rash Cream60 g in 1 TUBECREAM606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71630-549BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [DOTERRA INTERNATIONAL, LLC]6Current NDC, Legacy NDC, 1 package rows20250130_641465a1-0daf-1bb9-e053-2a91aa0ab25d.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 103 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50ZINC OXIDESOLARA SUNCARE, INC.f5242c7d-09e1-4141-8de1-a89bd7981ca62025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - TIME TRAVELER SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.f7ad1b52-6d9d-4a12-a6ab-6584ffc39cc92025-12-22WarningsExact identifier
application number: M020
Go Daily Defense Soothing Mineral Face Sunscreen SPF-30ZINC OXIDESOLARA SUNCARE, INC.fd040893-b1e5-783f-e053-6294a90ac2162025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.0fc8fadf-69fc-40ad-b4ca-d96dd2b30f952025-12-22WarningsExact identifier
application number: M020
GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK SPF-50ZINC OXIDESOLARA SUNCARE, INC.f3bb46e8-a9a5-b184-e053-2995a90afca72025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - POUT PROTECTOR SPF-15ZINC OXIDESOLARA SUNCARE, INC.ab6a326d-3b93-4122-a9f2-05e8203d31ef2025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - FORTUNE TELLER SPF-30ZINC OXIDESOLARA SUNCARE, INC.f434de33-5da8-57ef-e053-2a95a90a85022025-12-22WarningsExact identifier
application number: M020
SPF 50 Kids Sunscreen EquateAVOBENZONE, HOMOSALATE, OCTOCRYLENEWalmart Inc46919f43-2dee-57b1-e063-6294a90a15eb2025-12-22WarningsExact identifier
application number: M020
SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart Inc46919f45-e3f3-4ed0-e063-6294a90a98352025-12-22WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen daybreak Shimmer Sunscreen for the faceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bb734-d54d-e24e-e063-6394a90a1adb2025-12-21WarningsExact identifier
application number: M020
CabanaClear Illuminating SPF 50HOMOSALATE, OCTISALATE, AVOBENZONENAKED SUNDAYS PTY LTD47d1a39e-f645-c33d-e063-6394a90ad1ef2025-12-21WarningsExact identifier
application number: M020
THE MELT MIST Sheerest Mineral Mist Suncare for BodyTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.465d3277-7798-512a-e063-6294a90a20652025-12-20WarningsExact identifier
application number: M020
THE SLIP Invisible Cooling Suncare for Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.465e1ba2-e967-edb9-e063-6294a90aa31c2025-12-20WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7287078e-67ff-41fe-bc8d-59b2146f5dc92025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6095639-e2ee-418e-b4f1-e59da1bd92162025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8c6466a6-4f11-4210-bb02-eb31c15984cd2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior07f8282b-047b-4be1-8779-39ed5dd6fb5d2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5a8c67c1-aeba-490d-8347-a30916efcf3b2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior739450b0-8cd7-41de-8cd0-1827e02478c62025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior08b0e056-583a-474b-aaaa-ecea057030442025-12-19WarningsExact identifier
application number: M020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1125471zinc oxide 25 % Topical CreamPSN641465a1-0daf-1bb9-e053-2a91aa0ab25d6
1125471zinc oxide 250 MG/ML Topical CreamSCD641465a1-0daf-1bb9-e053-2a91aa0ab25d6
1125471zinc oxide 25 % Topical CreamSY641465a1-0daf-1bb9-e053-2a91aa0ab25d6
1125471ZNO 250 MG/ML Topical CreamSY641465a1-0daf-1bb9-e053-2a91aa0ab25d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71630-549-607163005496060 g in 1 TUBE (71630-549-60) 60 g2018-05-090000-00-00NoNoCurrent