FDA.reportPublic FDA data

Broad Spectrum SPF 15 Sunscreen Mint Lip Balm

Product NDC
65692-0571
11-digit product format
656920571
Labeler code
65692
Product ID
65692-0571_08a48426-8790-5d99-e063-6394a90a505c
Type
HUMAN OTC DRUG
Nonproprietary name
Broad Spectrum SPF 15 Sunscreen Mint Lip Balm
Dosage form
STICK
Route
TOPICAL
Labeler
Raining Rose
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-13
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OCTISALATE
Active strength
.13; .28; .06; .21 g/4.25g; g/4.25g; g/4.25g; g/4.25g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Broad Spectrum SPF 15 Sunscreen Mint Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE.13 g/4.25g
OCTINOXATE.28 g/4.25g
OCTOCRYLENE.06 g/4.25g
OCTISALATE.21 g/4.25g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
efe1113b-6101-0c15-e053-2a95a90a02a7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0571-1Broad Spectrum SPF 15 Sunscreen Mint Lip Balm4.25 g in 1 TUBESTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0571BROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALM STICK [RAINING ROSE]2Current NDC, 1 package rows20231027_efe1113b-6101-0c15-e053-2a95a90a02a7.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 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EcoZinc Natural Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386e23ec-7618-f42c-e063-6394a90a595d2025-11-27WarningsExact identifier
application number: M020
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65692-0571-1656920571014.25 g in 1 TUBE (65692-0571-1) 4.25 g2022-12-13NoNoCurrent