FDA.reportPublic FDA data

Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 12C

Product NDC
82109-101
11-digit product format
821090101
Labeler code
82109
Product ID
82109-101_2529db37-846f-1754-e063-6294a90af874
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Rare Beauty, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-30
Substance
TITANIUM DIOXIDE; HOMOSALATE; ZINC OXIDE
Active strength
18; 90; 9 mg/mL; 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
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 12C
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE18 mg/mL
HOMOSALATE90 mg/mL
ZINC OXIDE9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfee02eb-92f9-be12-e053-2a95a90a4337Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82109-101-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 12C30 mL in 1 BOTTLE, PLASTICLOTION304
82109-101-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 12C1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82109-101POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 14W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 22W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 26W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 12C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 20W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 10N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 24N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 16C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cfee02eb-92f9-be12-e053-2a95a90a4337.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 97 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Every Tone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incf3e3f4c6-2cb9-7b17-e053-2a95a90a38542025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Age Defense Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23f88c88-b68e-4706-e063-6294a90afb382025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd473113d-2fc3-6b1c-e053-2a95a90a88ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Incd89df7a5-7741-3e1d-e053-2995a90ae2752025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd475e14f-dab1-dec5-e053-2995a90aef732025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd4757d99-bac6-48fb-e053-2a95a90ab1bf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc24d3fbbc-0bce-b47a-e063-6394a90a9afa2025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme LightOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6894b9d9-a5b5-4c98-e053-2991aa0a9ca22025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme FairOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6892952a-d032-30bf-e053-2a91aa0a3bba2025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme Medium TanOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4e8b4-36cb-6306-e053-2a91aa0a6d252025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme MediumOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4ed34-f492-67a6-e053-2a91aa0a04282025-12-31WarningsExact identifier
application number: M020
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 SunscreenSUNSCREENMelaleuca Inc.1f1d1575-cf37-5d66-e063-6394a90ab2a32025-12-31WarningsExact identifier
application number: M020
Eucerin Daily HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Incc9bb7d33-783b-4cbb-a130-91f92d4cc1372025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e5326-73c3-9fa8-e053-2a95a90aae9d2025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e3f45-8e6f-6a3f-e053-2995a90a17d22025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Deep 550 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e31a82-0cd0-5a1a-e053-2991aa0a33f82025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2dfaa-d173-e6a9-e053-2a91aa0a46632025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 300 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c583-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30231-4fba-35d4-e053-2991aa0a33cb2025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 440 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-5640-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82109-101-01821090101011 BOTTLE, PLASTIC in 1 CARTON (82109-101-01) / 30 mL in 1 BOTTLE, PLASTIC2022-03-300000-00-00NoNoCurrent