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
V06SV4M95SInternal 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
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 324 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Personalized Day Moisturizer with SPFTITANIUM DIOXIDE, ZINC OXIDEProven Skincare3b6546ed-22ee-48e6-83cc-5cbadf5674992023-11-10WarningsExact identifier
application number: M020
Proven Personalized Day Moisturizer With SPF 50ZINC OXIDEProven Skincareba9b3cdc-c237-7ce2-e053-2995a90ac1752023-11-10WarningsExact identifier
application number: M020
MIAMI BEACH BUM Save Face SPF-30 SunscreenZINC OXIDEMIAMI BEACH BUM538742bc-d8f3-47d9-a85f-f2b1314f55072023-11-10WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)TITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4935f888-cd92-61d1-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M020
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a507-863f-1088-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M020
CoralSafe Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDEElements Brandse6e00896-b7e5-41c6-a72b-08e600758cf52023-11-10WarningsExact identifier
application number: M020
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a3ad-6379-108a-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M020
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolfb677ad0-2791-44ec-9720-951471ec009a2023-11-09WarningsExact identifier
application number: M020
Shaklee Youth Age Defense Mineral Moisturizer SPF 30TITANIUM DIOXIDEShaklee Corporationf4888fdc-09f9-43de-8c81-5a0f5e767d4e2023-11-09WarningsExact identifier
application number: M020
Raw Elements Eco 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLCbcce6d5b-d641-4484-a4dd-06b81170f8632023-11-09WarningsExact identifier
application number: M020
Spit and Polish Mineral Face SPF 30ZINC OXIDENaturally Uncommon, LLCaf86fca8-571c-0cac-e053-2a95a90ae4022023-11-09WarningsExact identifier
application number: M020
Raw Elements Tint 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC801a616a-5007-4951-8bc5-b8ffe9f0bb192023-11-09WarningsExact identifier
application number: M020
Raw Elements Baby Kids Broad Spectrum SPF30ZINC OXIDERaw Elements LLCfda8fce8-a164-45b5-b6ca-b1efce4740892023-11-09WarningsExact identifier
application number: M020
Raw Elements Lip Rescue 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC74b8eac3-4bc6-430b-b4b9-eabe3280d7af2023-11-09WarningsExact identifier
application number: M020
Raw Elements Baby Kids Broad Spectrum SPF30 SunscreenZINC OXIDERaw Elements LLCa6e5f808-65c7-4810-a15c-413111216dae2023-11-09WarningsExact identifier
application number: M020
Raw Elements Eco Formula 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC1d130543-9e12-42f4-80b4-915dbe0f85d42023-11-09WarningsExact identifier
application number: M020
Raw Elements Facial Moisturizer Tint Formula 30 SPF 30 Broad SpectrumZINC OXIDERaw Elements LLC8aff5517-8b3d-490e-b821-973baea2d0792023-11-09WarningsExact identifier
application number: M020
Raw Elements Daily Moisturizer Broad Spectrum SPF30ZINC OXIDERaw Elements LLC92c5f11b-5585-4479-8ee3-315c7e72574f2023-11-09WarningsExact identifier
application number: M020
Big Mood SPF 30 Milky Lip BalmZINC OXIDEEveryday Group Limitedc83098af-3cf9-78f6-e053-2995a90a0d012023-11-09WarningsExact identifier
application number: M020
Spit and Polish Sun Smart SunscreenTITANIUM DIOXIDE, ZINC OXIDENaturally Uncommon, LLCaf879a05-1483-5c11-e053-2995a90af45d2023-11-09WarningsExact 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