FDA.reportPublic FDA data

Intellishade TruPhysical SPF 45

Product NDC
64651-1003
11-digit product format
646511003
Labeler code
64651
Product ID
64651-1003_484d09cd-5b51-492b-e063-6294a90ac2db
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Revision, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-05
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
4.4; 14.4 g/100g; g/100g
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
Intellishade TruPhysical SPF 45
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE4.4 g/100g
ZINC OXIDE14.4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
e20f5dc9-e863-b090-e053-2a95a90a5044Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64651-1003-1Intellishade TruPhysical SPF 4548 g in 1 TUBELOTION4811
64651-1003-1Intellishade TruPhysical SPF 451 in 1 CARTONLOTION111
64651-1003-2Intellishade TruPhysical SPF 45227 g in 1 TUBELOTION22711
64651-1003-3Intellishade TruPhysical SPF 453 g in 1 TUBELOTION311

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 133 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC3750ffbf-a82d-b4b9-e063-6294a90a7d682025-12-11Exact identifier
application number: M020
The BlockZINC OXIDEELITE ESTHETICS BY NICOLE CAROLINE LLC34a6b17e-6e9e-3f2c-e063-6294a90a1c322025-12-11Exact identifier
application number: M020
SPF 40 Broad Spectrum Non-TintedZINC OXIDETeton Dermatology Holdings, Inc.35093797-008b-b265-e063-6294a90a99492025-12-11Exact identifier
application number: M020
Tinted Zinc ProtectionZINC OXIDETeton Dermatology Holdings, Inc.3508d5a8-9d3c-51d1-e063-6394a90abc8e2025-12-11Exact identifier
application number: M020
SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.35081ce0-2203-ab86-e063-6294a90aefd52025-12-11Exact identifier
application number: M020
Antioxidant SPFZINC OXIDETeton Dermatology Holdings, Inc.3509a916-f3e1-9c53-e063-6394a90a5bff2025-12-11Exact identifier
application number: M020
Ultimate Physical Sunscreen TintedZINC OXIDEHALEM DERMATOLOGY PLLC35bb4953-ca8c-e927-e063-6394a90a1a312025-12-11Exact identifier
application number: M020
Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.3509eea7-f966-2080-e063-6294a90aeeb52025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHALEM DERMATOLOGY PLLC35bce44e-d9f4-9279-e063-6394a90a64532025-12-11Exact identifier
application number: M020
Ultimate Physical SunscreenZINC OXIDEHALEM DERMATOLOGY PLLC35bc5ff5-8eb8-54cf-e063-6394a90ae3c22025-12-11Exact identifier
application number: M020
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350ad191-e51c-083d-e063-6394a90aa6462025-12-11Exact identifier
application number: M020
Ultimate Physical SunscreenZINC OXIDEHALEM DERMATOLOGY PLLC35be5dc0-861f-3738-e063-6394a90a23ca2025-12-11Exact identifier
application number: M020
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350b2246-6e00-38fc-e063-6294a90ae3822025-12-11Exact identifier
application number: M020
Calming Protection SPF40ZINC OXIDEFRESH FACED SKIN CARE LLC35d0c081-67b4-ce46-e063-6294a90ad8222025-12-11Exact identifier
application number: M020
Tinted Facial Protection SPF40TITANIUM DIOXIDE, ZINC OXIDEFRESH FACED SKIN CARE LLC35d08e2a-b118-8634-e063-6294a90a918d2025-12-11Exact identifier
application number: M020
Total Body Block SunscreenZINC OXIDETHE COMPLEXIONIST38f53f6a-8e68-e30f-e063-6394a90afef22025-12-11Exact identifier
application number: M020
Fair Skin Anti-AgingZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351bb329-90ea-f19a-e063-6394a90af1072025-12-11Exact identifier
application number: M020
Oil Free Anti-AgingZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351b4870-d9bd-c356-e063-6394a90a77632025-12-11Exact identifier
application number: M020
Anti-Aging Sun Protection NTTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351a20df-bd8a-8ea6-e063-6294a90abaaf2025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64651-1003-1646511003011 TUBE in 1 CARTON (64651-1003-1) / 48 g in 1 TUBE1 tube2018-03-050000-00-00NoNoCurrent
64651-1003-264651100302227 g in 1 TUBE (64651-1003-2) 227 g2018-03-050000-00-00NoNoCurrent
64651-1003-3646511003033 g in 1 TUBE (64651-1003-3) 3 g2018-03-050000-00-00YesNoCurrent