FDA.reportPublic FDA data

Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 48W

Product NDC
82109-142
11-digit product format
821090142
Labeler code
82109
Product ID
82109-142_2471f422-a721-3d3f-e063-6294a90a077f
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Rare Beauty, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-01
Substance
HOMOSALATE; ZINC OXIDE
Active strength
65; 57 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 48W
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE65 mg/mL
ZINC OXIDE57 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
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
2471e0fa-ddc8-1c62-e063-6294a90a4408Available 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82109-142-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 48W1 in 1 CARTONLOTION11
82109-142-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 48W30 mL in 1 BOTTLE, PLASTICLOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82109-142POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N (HOMOSALATE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]1Current NDC, 2 package rows20241102_2471e0fa-ddc8-1c62-e063-6294a90a4408.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 60 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bad1502-bc44-54ec-e063-6294a90ace8b2026-02-25WarningsExact identifier
application number: M020
Truskin SPF 30 Mineral Sunscreen Facial SerumZINC OXIDEAllure Labs2e20c132-8a03-1d5d-e063-6394a90ad2c32026-02-25WarningsExact identifier
application number: M020
Rationale The Brilliance Tinted Serum SPF 50ZINC OXIDERATIONALE GROUP PTY LTD5c38506b-1533-435f-87a6-0452bae5b29f2026-02-24WarningsExact identifier
application number: M020
FULLY RICE CERAMIDE MOISTURE SUNSCREENZINC OXIDEAdapt Inc.d8bfe222-3184-4c98-9876-ef5ac81772b62026-02-24WarningsExact identifier
application number: M020
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
application number: M020
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
application number: M020
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
application number: M020
Reunited Lipgloss SPF 30 - BTCH IS BACKHOMOSALATE, OCTOCRYLENE, OCTISALATEPrinceville Productions, LLC, DBA Reunited Beauty4b961531-fbca-d1cf-e063-6294a90ab9a12026-02-24WarningsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.8f5e634c-765b-4ffe-bb12-753d64c90cf92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.e97bf30a-1465-4912-bd55-1e7dd993132b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.67efcd94-00af-477b-bd14-d1c7b95d305a2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f3d2e1e-1e95-4719-8ca9-83b6b804ab9f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen Mist SPF 100AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f642788c-3643-459a-b736-0c06d0cd32a92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.95ba2b33-f593-4e95-bd6e-5910d6aa51582026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3b85004a-8832-4eac-bd70-1e607ae7af4b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.7f0fc23b-2d70-4426-9d64-a6d2b643309f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.0ae9edd8-bf76-4bb2-ab78-c43c017ba4a52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f8960995-66b6-4197-8976-b318fe01488f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82109-142-01821090142011 BOTTLE, PLASTIC in 1 CARTON (82109-142-01) / 30 mL in 1 BOTTLE, PLASTIC2024-11-01NoNoCurrent