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 32 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frase Skin SPF 30 Face Sunscreen Activated Vitamin D TechnologyAVOBENZONE, OCTISALATE, OCTOCRYLENEFrase Skin PTY LTDd904fd23-a3a1-4564-8eec-13a4c96e23f72026-05-12WarningsExact identifier
application number: M020
Hawaii Sol Natural Non-Nano Sunscreen SPF 50ZINC OXIDECaribbean Sol International, LLC24678326-547f-427d-a481-d8c40380e30a2026-05-12WarningsExact identifier
application number: M020
Caribbean Sol Natural Non-Nano Sunscreen SPF 50ZINC OXIDECaribbean Sol International, LLC20aadcf6-16a3-4344-837b-b91ba8753fb02026-05-12WarningsExact identifier
application number: M020
Cancer Council Daily Face Moisturizer SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1b4333b8-5747-c591-e063-6294a90a99242026-05-12WarningsExact identifier
application number: M020
Lather Daily Defense Mineral SPF 45 Facial SunscreenZINC OXIDELather, Inc.50c732a0-b282-d61b-e063-6294a90aa76b2026-05-12WarningsExact identifier
application number: M020
Hampton Sun SPF50 Mineral Face SunscreenHOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%S&C Hampton Sun LLCf1c5310b-c43b-475d-8a50-d55759ad31642026-05-12WarningsExact identifier
application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
application number: M020
Stellar Mineral Glow Guard Sunscreen Broad Spectrum SPF 50ZINC OXIDEStellar Beauty Co.0f7ee8c6-3af2-42a2-b341-3e0da42c7c932026-05-11WarningsExact identifier
application number: M020
Frase Skin SPF 50 Activated Vitamin D Technology CoolAVOBENZONE, OCTISALATE, OCTOCRYLENEFrase Skin PTY LTD0a5cc927-0fd3-4c8f-b847-a274f6eb09fb2026-05-11WarningsExact identifier
application number: M020
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral SunscreenZINC OXIDEMiami Beach Bum3b778530-9af0-48eb-bd91-d9ac99f2983f2026-05-11WarningsExact identifier
application number: M020
Walgreens SPF 60 Melt-in Milk SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalgreens345955ea-f37a-8629-e063-6294a90aa7cc2026-05-11WarningsExact identifier
application number: M020
DERMATONE SPF50 SunscreenAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Dermatone Labs LLC4dc81593-4790-403f-9d49-6569bcd0fea22026-05-11WarningsExact identifier
application number: M020
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
application number: M020
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact identifier
application number: M020
ChapStick Moisturizer Original SPF 15SPF 15 SKIN PROTECTANTSuave Brands Co., LLC47bfa8ea-4d8d-cd13-e063-6394a90a71aa2026-05-11WarningsExact identifier
application number: M020
EELHOE SunscreenTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5196ccb0-4515-7e40-e063-6394a90a09bd2026-05-11WarningsExact identifier
application number: M020
Mediheal Madecassoside Moisture Sun SerumHOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLE7400547c66535-8287-9b74-e063-6394a90ac3b62026-05-10WarningsExact identifier
application number: M020
SPF 30 SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLCaf56f16a-2643-4bfc-9e05-dfba79cdab8a2026-05-08WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Cool GlowZINC OXIDEIris and Romeo514f7d70-7b8b-0992-e063-6394a90a1e982026-05-08WarningsExact 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