FDA.reportPublic FDA data

Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30

Product NDC
84448-344
11-digit product format
844480344
Labeler code
84448
Product ID
84448-344_4249cc90-05f6-ae01-e063-6294a90ac4fb
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
THG Beauty USA LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-08
Substance
ZINC OXIDE
Active strength
17.68 g/100mL
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
Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17.68 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cd10158-c346-60c9-e063-6294a90a54bdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84448-344-11Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30100 mL in 1 TUBECREAM1003
84448-344-11Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 301 in 1 CARTONCREAM13
84448-344-20Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 3020 mL in 1 TUBECREAM203
84448-344-20Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 301 in 1 CARTONCREAM13
84448-344-50Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 301 in 1 CARTONCREAM13
84448-344-50Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 3050 mL in 1 TUBECREAM503

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 113 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV Defense Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e2498-7df2-f22c-e063-6294a90ac6ab2025-12-16Exact identifier
application number: M020
UV Protection Veil Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3bf5a6-33ec-0255-e063-6294a90ac96a2025-12-16WarningsExact identifier
application number: M020
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3cba2e-acc6-a2df-e063-6294a90abf712025-12-16WarningsExact identifier
application number: M020
Color Smart Tinted MineralZINC OXIDEMEGAN YORK INC.365c4623-94d5-e8b6-e063-6394a90a966a2025-12-16Exact identifier
application number: M020
Anti-Aging Tinted SunscreenZINC OXIDEKARINA SALDIVAR3bca508e-7bd0-d45d-e063-6394a90a17302025-12-16WarningsExact identifier
application number: M020
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3c757f-6581-4978-e063-6294a90a61732025-12-16WarningsExact identifier
application number: M020
Kind Restore Tinted Mineral SunscreenZINC OXIDEPOLISH BEAUTY3980810f-58b5-3a60-e063-6294a90a9c072025-12-16Exact identifier
application number: M020
Daydream Beyond ScreenZINC OXIDEULTRAVIOLET SKINCARE LLC36bfd963-d123-0d25-e063-6294a90aa8272025-12-16Exact identifier
application number: M020
Virgo SOL Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d4f43-8c57-9fcf-e063-6294a90aa9162025-12-16Exact identifier
application number: M020
Virgo SOL Non Tinted MousseTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d63a9-b9ab-9530-e063-6394a90ac8ef2025-12-16Exact identifier
application number: M020
Kind Restore Tinted Mineral SunscreenZINC OXIDEPOLISH BEAUTY3980d278-c0f4-2c59-e063-6394a90aac372025-12-16Exact identifier
application number: M020
Solar Eclipse Extreme SunscreenZINC OXIDEULTRAVIOLET SKINCARE LLC36bfa691-48c0-8033-e063-6294a90ad8992025-12-16Exact identifier
application number: M020
Kind Restore Moisturizing Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPOLISH BEAUTY39814e27-4f3f-5ee6-e063-6394a90a941b2025-12-16Exact identifier
application number: M020
Yoali SPF 40ZINC OXIDEYOALI STUDIO LLC390b7f9c-bc04-80ec-e063-6294a90a40922025-12-16Exact identifier
application number: M020
Skin Defense Matte Tinted SunscreenZINC OXIDEGentlehomme LLC365eb727-3e7f-f1dd-e063-6394a90aa4692025-12-16Exact identifier
application number: M020
Dr B Clinical Skin Care Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365da1f8-5250-7589-e063-6294a90a3e682025-12-16Exact identifier
application number: M020
Dr B Clinical Skin Care Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365d7564-3025-257b-e063-6294a90ad1702025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEGentlehomme LLC365e7d8e-e3e0-4c08-e063-6294a90af4152025-12-16Exact identifier
application number: M020
Daily Replenish mineral sunscreenZINC OXIDEPURE VITALITY SKIN AND BODY, INC369896b1-f4b4-6201-e063-6394a90a5bca2025-12-16Exact identifier
application number: M020
Zinc 20 mineral sunscreen face Plus bodyZINC OXIDEPURE VITALITY SKIN AND BODY, INC36985373-22dd-2232-e063-6394a90a76fb2025-12-16Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84448-344-11844480344111 TUBE in 1 CARTON (84448-344-11) / 100 mL in 1 TUBE1 tube2024-07-08NoNoCurrent
84448-344-20844480344201 TUBE in 1 CARTON (84448-344-20) / 20 mL in 1 TUBE1 tube2024-07-08NoNoCurrent
84448-344-50844480344501 TUBE in 1 CARTON (84448-344-50) / 50 mL in 1 TUBE1 tube2024-07-08NoNoCurrent