FDA.reportPublic FDA data

Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen

Product NDC
59735-920
11-digit product format
597350920
Labeler code
59735
Product ID
59735-920_4f846c80-70f8-7a19-e063-6294a90a3d84
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
PML NYC, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
50; 50 mg/mL; mg/mL
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
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen
Brand name suffix
Tan-Deep
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE50 mg/mL
ZINC OXIDE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1be639a8-179a-7015-e063-6394a90ab64bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-920-01Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 SunscreenTan-Deep50 mL in 1 TUBECREAM508
59735-920-02Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 SunscreenTan-Deep1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-920AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN IVORY (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN LIGHT (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN LIGHT-MEDIUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN MEDIUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN MEDIUM-TAN (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN TAN (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN TAN-DEEP (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MANA PRODUCTS, INC]6Current NDC, 2 package rows20240906_1be639a8-179a-7015-e063-6394a90ab64b.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 329 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.C.Tuna Sun Body SPF50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketi250d8b0c-729b-4a0d-b6b0-2c9fdbc661972023-11-05WarningsExact identifier
application number: M020
Farmasi BBAVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI042817f9-675e-056a-e063-6394a90a2d972023-11-05WarningsExact identifier
application number: M020
JACKET SPF 50ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATEBalshi MD Dermaceuticalsb82b8a46-8009-416e-8718-296a231069142023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton CandyHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC6ccd648f-ec3b-4325-8d89-b5dd10c2fff72023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton CandyHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC43c84cab-e35b-4808-bcc5-399573aef3b42023-11-05WarningsExact identifier
application number: M020
NO BS Moisturizer SPF20OCTINOXATE, OCTISALATE, AVOBENZONEProduct Management, LLC142f3610-85da-408d-8fa5-3773167ffc9f2023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Coco LimeHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC63b252c4-7d02-475b-97aa-57ef9c2e52ad2023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Coco LimeHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC533b6106-7f6f-49b9-9670-e2050bfcb9322023-11-05WarningsExact identifier
application number: M020
VERTRA Premium Suncare SPF 30TITANIUM DIOXIDE, ZINC OXIDEEai-Jr286, Inc.720ca725-24ca-4b59-b640-afa9832386922023-11-05WarningsExact identifier
application number: M020
BEACH GYPSY Glitter Sunscreen SPF 30OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEMJ Products Association, LLC1d224ecf-d356-424e-b181-ad8692f82b032023-11-05WarningsExact identifier
application number: M020
BEAST HYDRATING FACE SPF-20OCTOCRYLENE, OCTISALATE, AVOBENZONESmall Batch Beauty, LLC37941628-9f4f-474e-a8d9-080f4c6631122023-11-05WarningsExact identifier
application number: M020
NAELI Day Moisturizer SPF 30OCTISALATE, OCTOCRYLENE, AVOBENZONEAlli LLC9fe2f5c4-cf20-207e-e053-2a95a90ac54f2023-11-05WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1COCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4c9ffd30-4799-475d-94cb-07ce3d5b36602023-11-04WarningsExact identifier
application number: M020
enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENEShaklee Corporationc57bfab7-f67c-435b-8703-e2051cfd097e2023-11-03WarningsExact identifier
application number: M020
Youth 2 Activating BB Cream SPF 30 Light MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporatione51e38c9-cc9b-4af3-842d-41d0162f17ff2023-11-03WarningsExact identifier
application number: M020
Youth 4 Activating BB Cream SPF 30 DarkZINC OXIDE, TITANIUM DIOXIDEShaklee Corporation63f7f8bd-02f0-4a13-bb1e-298754b24fce2023-11-03WarningsExact identifier
application number: M020
Youth 1 Activating BB Cream SPF 30 LightZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationc9e05055-48ea-405d-b1d4-50b263d0dbf92023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Diorfe03fc14-4132-4dab-b013-d490764be0d42023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior968cfae7-89b6-4ef3-ab60-1c675b90c1512023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1NENSULIZOLE, OCTISALATEParfums Christian Diord2ca01ad-68b2-4312-a9d0-04d3e992bb132023-11-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59735-920-015973509200150 mL in 1 TUBE50 mlHistorical
59735-920-02597350920021 TUBE in 1 CARTON (59735-920-02) / 50 mL in 1 TUBE (59735-920-01) 1 tube2004-05-01NoNoCurrent