FDA.reportPublic FDA data

Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 36C

Product NDC
82109-112
11-digit product format
821090112
Labeler code
82109
Product ID
82109-112_2529c6c8-ac92-b675-e063-6294a90afc6b
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 36C
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
cffb8219-7076-de64-e053-2a95a90a6036Available 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
82109-112-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 36C30 mL in 1 BOTTLE, PLASTICLOTION304
82109-112-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 36C1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82109-112POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 28C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 30N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 32N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 34W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 36C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 38N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 40N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 42N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cffb8219-7076-de64-e053-2a95a90a6036.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 138 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31177bbd-68b0-8b24-e063-6294a90aa8d82025-12-10WarningsExact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3118c3ed-f0f0-f997-e063-6294a90a53a92025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3117faeb-1792-1b2e-e063-6294a90a92df2025-12-10WarningsExact identifier
application number: M020
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
application number: M020
Morning ReplenishZINC OXIDERestore Skin Therapy, LLC364b26c2-a1bb-9660-e063-6294a90a14d12025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC34288989-35b8-3aa3-e063-6394a90ac2c42025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC3418394b-fede-65ce-e063-6394a90ad5f92025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC341871e5-c170-7560-e063-6394a90a8eee2025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC3428bdbb-1f18-a29b-e063-6294a90addbc2025-12-10Exact identifier
application number: M020
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
application number: M020
Sheer Mineral Sunscreen BarTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b69d5-f0e1-99cd-e063-6294a90abb6e2025-12-10Exact identifier
application number: M020
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342c3f42-c17f-f777-e063-6394a90a80582025-12-10Exact identifier
application number: M020
Lip SPFTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396d3fdd-99d8-77e8-e063-6294a90aec2f2025-12-10Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396cae82-7641-e1b2-e063-6394a90a7c072025-12-10Exact identifier
application number: M020
Solar Knight SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEMASCARENAS ENTERPRISES, INC.36c27c91-22ac-205c-e063-6294a90ab3792025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396ce15a-06ad-4055-e063-6294a90a27fb2025-12-10Exact identifier
application number: M020
Dermablue Daily ReplenishingZINC OXIDEDermablue, P.C.308da9c9-544e-d5d1-e063-6294a90aa49b2025-12-10WarningsExact identifier
application number: M020
Recoverie Mineral MatteZINC OXIDEClear Day Acne Clinic308f41de-fb14-40f9-e063-6394a90a008f2025-12-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82109-112-01821090112011 BOTTLE, PLASTIC in 1 CARTON (82109-112-01) / 30 mL in 1 BOTTLE, PLASTIC2022-03-300000-00-00NoNoCurrent