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 157 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KOVR Military grade sunscreen for MenZINC OXIDEACTIVE LIFE INCc9fbbc6e-6284-4308-89a3-98300c3a03202025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sensitive Mineral SPF 50ZINC OXIDEThe Hain Celestial Group, Inc.4484b16f-f29a-60cc-e063-6294a90a2b9d2025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF50ZINC OXIDEThe Hain Celestial Group, Inc.0cf9c4b9-8e85-980c-e063-6394a90a9e7e2025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sensitive Mineral SPF 30ZINC OXIDEThe Hain Celestial Group, Inc.44867882-d9c1-7389-e063-6294a90a7f772025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF30ZINC OXIDEThe Hain Celestial Group, Inc.0cf9361f-f292-6429-e063-6294a90add0e2025-11-26WarningsExact identifier
application number: M020
ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.ec8386f2-9cb7-40f4-e053-2995a90ac2d82025-11-26WarningsExact identifier
application number: M020
WOODSLEEP Tallow SunscreenTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.330a9f2e-7ce1-f83f-e063-6394a90a184a2025-11-26WarningsExact identifier
application number: M020
WOODSLEEP Tallow SunscreenTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.33cdde09-e7ee-e003-e063-6394a90a87622025-11-26WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company44718c3c-b081-bcfb-e063-6394a90a37862025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4472cc1e-6b34-388b-e063-6394a90ac7b62025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4472ef69-8992-fcab-e063-6294a90a6b902025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company44732f89-8ac3-8c5d-e063-6394a90aba732025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company447347d6-b8a3-7338-e063-6294a90abbf92025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4473c4cc-f8b5-4a92-e063-6394a90ae6902025-11-25WarningsExact identifier
application number: M020
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
application number: M020
Safe Sea SPF 50 MineralZINC OXIDENidaria Technology Ltd.f6cf9454-552b-486e-a38b-ab3c183b24a12025-11-24WarningsExact identifier
application number: M020
Safe Sea SPF 30ZINC OXIDENidaria Technology Ltd.91bf07ed-0be4-43c9-b5f3-4e8eb892bca52025-11-24WarningsExact identifier
application number: M020
Olay Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company5904baa8-3070-1d77-e053-2a91aa0a68522025-11-24WarningsExact identifier
application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact identifier
application number: M020
Cetaphil Sun Tinted Face SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.22413f93-7219-4726-b741-2392e576b34a2025-11-24WarningsExact 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