FDA.reportPublic FDA data

Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 58N

Product NDC
82109-147
11-digit product format
821090147
Labeler code
82109
Product ID
82109-147_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 58N
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
82109-147-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 58N30 mL in 1 BOTTLE, PLASTICLOTION301
82109-147-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 58N1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82109-147POSITIVE 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 154 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Super Leaves Lip Balm SPF15 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff1fc0-9ac5-2c9a-e063-6294a90a46322025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff5675-fd8d-b665-e063-6294a90a1e0b2025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 PineappleZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ffb35b-80f4-7ddb-e063-6394a90a2cbb2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44ffd469-0205-846f-e063-6294a90af6b52025-12-02WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.daf0291e-770c-eaf2-e053-2a95a90a0b672025-12-01WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Dewy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE7054144e0098c-170f-ca51-e063-6294a90aed202025-12-01WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Sun EssenceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e194cd-ea61-71b3-e063-6394a90ac4862025-12-01WarningsExact identifier
application number: M020
Venture Performance Sun Protection Mineral Sunscreen SPF 50ZINC OXIDEVenture Performance Inc630fc5c2-a315-4e26-9bd9-5f8533d759082025-12-01WarningsExact identifier
application number: M020
EMINENCE Red Currant Protective MoisturizerOCTINOXATE, ZINC OXIDEEminence Organic Skin Care7eca62af-6f70-44ec-879e-74712163c4e02025-12-01WarningsExact identifier
application number: M020
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless PrimerAVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENECharlotte Tilbury Beauty Ltd.2b215ecb-7c3a-63db-e063-6394a90aa88f2025-12-01WarningsExact identifier
application number: M020
P.CALM Water Barrier Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONELIFE WITHCORPORATION Inc.44ea9fb4-8e01-6969-e063-6294a90a6a942025-12-01WarningsExact identifier
application number: M020
ROC MULTI CORREXION - EVEN TONE AND LIFT - 5-In-1 Chest, Neck, and Face Cream Sunscreen - Broad Spectrum SPF 30AVOBENZONE, HOMOSALATA, OCTISALATE, OCTOCRYLENERoc Skincare2b3656d6-4b3a-9ef2-e063-6294a90acaa62025-12-01WarningsExact identifier
application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERare Beauty Brands Inc.44ec0db5-4437-e4a3-e063-6294a90a9a002025-12-01WarningsExact identifier
application number: M020
RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare2888a198-116b-8441-e063-6394a90a0f952025-12-01WarningsExact identifier
application number: M020
ReefSafe Very High Sun Protection sunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ec619f-ed3b-2fd3-e063-6294a90a858b2025-12-01WarningsExact identifier
application number: M020
Reef safe - Face and Body sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38603298-e8da-e4c7-e063-6394a90aca3b2025-12-01WarningsExact identifier
application number: M020
ReefSafe Baby and Toddlers Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44dd513e-ebaa-0d6a-e063-6394a90a78b72025-11-30WarningsExact identifier
application number: M020
Safe4Kidz Natural Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ddc0ae-a977-3adf-e063-6294a90a08982025-11-30WarningsExact identifier
application number: M020
Safe4Kidz Baby Zinc Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ddc4d8-3f3b-5d11-e063-6294a90ae88a2025-11-30WarningsExact identifier
application number: M020
Clarite Makeup Foundation for a Clearer Appearance SPF 30 170-NOCTINOXATE, ZINC OXIDEBEL STAR S Ab56f5883-be57-e0e5-e053-2a95a90adb0c2025-11-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82109-147-01821090147011 BOTTLE, PLASTIC in 1 CARTON (82109-147-01) / 30 mL in 1 BOTTLE, PLASTIC2024-11-01NoNoCurrent