FDA.reportPublic FDA data

Resist Wrinkle Defense SPF 30

Product NDC
56152-5003
Requested package NDC
56152-5003-1
11-digit product format
561525003
Labeler code
56152
Product ID
56152-5003_5f6354b3-2f7e-c83b-e063-6394a90a652a
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmetic Enterprises Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-10
Substance
ZINC OXIDE
Active strength
13 g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Resist Wrinkle Defense SPF 30
Brand name suffix
Paulas Choice
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE13 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56152-5003-1Resist Wrinkle Defense SPF 30Paulas Choice60 mL in 1 TUBECREAM606
56152-5003-2Resist Wrinkle Defense SPF 30Paulas Choice1.5 mL in 1 PACKETCREAM1.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56152-5003RESIST WRINKLE DEFENSE SPF 30 PAULAS CHOICE (ZINC OXIDE) CREAM [COSMETIC ENTERPRISES LTD]5Current NDC, Legacy NDC, 2 package rows20241105_d658fdc7-9dac-47bf-8e83-1433a29a6cf6.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 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HERA SILKYSTAY FOUNDATION 37W1TITANIUM DIOXIDEAmorepacific Corporation5f4105f3-d08b-edb5-e063-6394a90ad28b2026-11-01WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 130 Cool RoseOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIc52d92d9-e228-4840-aacc-ed97a61734432026-10-29WarningsExact identifier
application number: M020
HERA SILKYSTAY FOUNDATION 28O1TITANIUM DIOXIDEAmorepacific Corporation5ec77f7a-4621-ac0c-e063-6294a90a3f702026-10-26WarningsExact identifier
application number: M020
RoC Barrier Renew AM Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare020aa79f-4fd6-1ea1-e063-6394a90a44642026-10-14WarningsExact identifier
application number: M020
Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15AVOBENZONE, OCTOCRYLENEMerle Norman Cosmetics, Incd5c97cdc-7f98-1a4f-e053-2995a90a089b2026-10-12WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-10-02WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC52bbc6cd-4bc2-7859-e063-6394a90ac87d2026-10-01WarningsExact identifier
application number: M020
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349404zinc oxide 13 % Topical CreamPSNd658fdc7-9dac-47bf-8e83-1433a29a6cf66
349404zinc oxide 130 MG/ML Topical CreamSCDd658fdc7-9dac-47bf-8e83-1433a29a6cf66
349404zinc oxide 13 % Topical CreamSYd658fdc7-9dac-47bf-8e83-1433a29a6cf66
349404ZNO 130 MG/ML Topical CreamSYd658fdc7-9dac-47bf-8e83-1433a29a6cf66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56152-5003-15615250030160 mL in 1 TUBE (56152-5003-1) 60 ml2016-08-100000-00-00NoNoCurrent