FDA.reportPublic FDA data

Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 22W

Product NDC
82109-129
11-digit product format
821090129
Labeler code
82109
Product ID
82109-129_2460270d-27ad-00d5-e063-6394a90a9a6c
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 22W
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
2460281d-d433-0216-e063-6394a90a9d48Available 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
82109-129-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 22W30 mL in 1 BOTTLE, PLASTICLOTION301
82109-129-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 22W1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82109-129POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 20W (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 10N (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 12C (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 24N (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 14W (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 22W (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 16C (HOMOSALATE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 26W (HOMOSALATE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]1Current NDC, 2 package rows20241102_2460281d-d433-0216-e063-6394a90a9d48.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 127 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen Stick SPF 50 Fragrance-FreeZINC OXIDECOOLA LLCee8706b0-ad42-403a-be7c-b660f040a2442025-12-14WarningsExact identifier
application number: M020
COOLA CLASSIC SUNSCREEN FRAGRANCE FREEAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCcfc21b1a-4a26-1573-e053-2995a90a2d502025-12-14WarningsExact identifier
application number: M020
Kopari Sunglaze Sheer Body Mist Sunscreen SPF42AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKopari Beauty7c96b799-e24d-473f-8f0a-3fad83d5ed482025-12-14WarningsExact identifier
application number: M020
WOODSLEEP Sunscreen BalmTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.45cfc7ed-34a6-1f45-e063-6394a90a902b2025-12-13WarningsExact identifier
application number: M020
Universkin by Alma Daily Mineral Serum Broad Spectrum SPF50ZINC OXIDE 24%UNIVERSKIN45d242de-cbd8-e7ea-e063-6394a90aaebf2025-12-13WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE SPF 50ALAINA HEALTHCARE PRIVATE LIMITEDb7847d4f-2517-4b58-8e31-676c9d6e484d2025-12-12WarningsExact identifier
application number: M020
Lip ProtectingTITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544b8f2-2651-4c01-e063-6394a90ae53d2025-12-12Exact identifier
application number: M020
Tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544faa1-ebdf-5dbd-e063-6394a90a76312025-12-12Exact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC40323dfa-29e4-1464-e063-6294a90aa65c2025-12-12WarningsExact identifier
application number: M020
Zinc 20Percent SPF 40ZINC OXIDEJOHANNA'S SKIN CARE3545ed3e-b42f-d29d-e063-6394a90a8efe2025-12-12Exact identifier
application number: M020
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC40332cf3-e4e5-0c00-e063-6394a90a683d2025-12-12WarningsExact identifier
application number: M020
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032913b-4bc3-6920-e063-6294a90a6e2d2025-12-12WarningsExact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032f0b0-c083-d227-e063-6394a90a30682025-12-12WarningsExact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396d952b-22ff-567f-e063-6394a90a8c682025-12-12Exact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396dfc9c-b6c0-5892-e063-6394a90a110c2025-12-12Exact identifier
application number: M020
KawaKids KawaSun - Premium Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f41f64b-d707-08e2-e063-6294a90aa9242025-12-12WarningsExact identifier
application number: M020
KawaKids KawaSun - Premium On-The-Go Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f4341f7-b499-3b73-e063-6394a90a75b82025-12-12WarningsExact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f7f72-c426-e42f-e063-6294a90a4b3a2025-12-12Exact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f06f3-9deb-4c1a-e063-6394a90ad7662025-12-12Exact identifier
application number: M020
Daily Mineral ProtectionZINC OXIDECharisma Skin352d72f6-06b9-6fdc-e063-6294a90ab4482025-12-12Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82109-129-01821090129011 BOTTLE, PLASTIC in 1 CARTON (82109-129-01) / 30 mL in 1 BOTTLE, PLASTIC2024-11-01NoNoCurrent