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 302 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30OCTOCRYLENE, ZINC OXIDESOLVADERM LLC0f9a507a-1b72-45f8-a8a8-b7a92a85607f2024-03-21WarningsExact identifier
application number: M020
Daily Prevention Protect and Refresh Mist SPF 40AVOBENZONE, OCTISALATE AND OCTOCRYLENEAllure Labs142f99de-176e-ad11-e063-6394a90a935b2024-03-21WarningsExact identifier
application number: M020
PHYSIOGEL Daily Moisture Therapy Barrier Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEfmg Co.Ltd1410c6d9-eff0-f90b-e063-6394a90a94032024-03-20WarningsExact identifier
application number: M020
ETADERM Tattoo Sunscreen Broad Spectrum SPF-30ZINC OXIDENUEPHASE LLCcc1e3485-57e6-4ac9-96b3-2d683beb5b532024-03-20WarningsExact identifier
application number: M020
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs141bb721-cd1c-5bba-e063-6394a90ab8fa2024-03-20WarningsExact identifier
application number: M020
Sunscreen-LotionZINC OXIDE, TITANIUM DIOXIDEShanghai Chuangshi Medical Technology (Group) Co., Ltd.0511ff57-b7bd-4708-e063-6294a90a58a82024-03-20WarningsExact identifier
application number: M020
Daily Prevention Ultra Defense Moisturizer SPF 50HOMOSALATE, OCTISALATE,OCTOCRYLENE AND ZINC OXIDEAllure Labs14070076-8c57-e2f1-e063-6394a90a0dfc2024-03-19WarningsExact identifier
application number: M020
PHYSIOGEL Daily Moisture Therapy Barrier Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDELG H&H Co., Ltd.140feb1e-a72f-ade4-e063-6394a90a11fb2024-03-19WarningsExact identifier
application number: M020
Daily Prevention Sheer Matte Moisturizer SPF30HOMOSALATE AND OCTISALATE AND ZINC OXIDEAllure Labs13b5c78c-f950-699b-e063-6294a90a98982024-03-15WarningsExact identifier
application number: M020
Daily Prevention Pure Mineral Tinted Moisturizer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs13bc141b-a30f-2661-e063-6294a90aca2b2024-03-15WarningsExact identifier
application number: M020
BB Ambre 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13a3ec97-0d0a-d639-e063-6294a90a0bf82024-03-14WarningsExact identifier
application number: M020
Mineral ShakeZINC OXIDEVacation Inc.131b7e65-7155-f925-e063-6394a90a1d7a2024-03-13WarningsExact identifier
application number: M020
BB Blanc 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137a1528-c487-8bf3-e063-6294a90ade842024-03-12WarningsExact identifier
application number: M020
BB Sienna 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137bff4a-5156-b12c-e063-6394a90abe632024-03-12WarningsExact identifier
application number: M020
Vacation SuperAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc.137c350b-dca1-47f7-e063-6294a90a531e2024-03-12WarningsExact identifier
application number: M020
Avene Hydrance Moisturizing SPF 30ZINC OXIDEPierre Fabre USA Inc.1361ebe5-2659-d88f-e063-6294a90a71bb2024-03-11WarningsExact identifier
application number: M020
BB Brite 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13660aee-3b28-7e3e-e063-6294a90a82cc2024-03-11WarningsExact identifier
application number: M020
BB Bronze 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13679e50-01ef-9a8f-e063-6294a90ac5772024-03-11WarningsExact identifier
application number: M020
Advanced Firming And Anti-Wrinkle Day SPF 18 EQBAVOBENZONE 2% OCTISALATE 5% OCTOCRYLENE 5%Walmart358dfed4-1c6d-400e-8e6f-331fbc76a8342024-03-11WarningsExact identifier
application number: M020
Avene Mineral Sunscreen Stick SPF 50ZINC OXIDEPierre Fabre USA Inc.1368482f-3a72-ffa9-e063-6394a90a603e2024-03-11WarningsExact 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