Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50

Manufacturer
THG Beauty USA LLC
Effective date
2025-11-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:30:08

Label at a glance#

ProductBiossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5.14%

Zinc Oxide 5.74%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by exposure to the sun.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use.
  • Apply generously to face and neck 15 minutes before sun exposure.
  • Use water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeved shirts, pants, hats, and sunglasses.

  • Children under 6 months of age: Ask a doctor.

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, PENTYLENE GLYCOL, GLYCERIN, SQUALANE, SILICA, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALUMINA, HYDROGENATED LECITHIN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PROPANEDIOL, STEARIC ACID, NIACINAMIDE, JOJOBA ESTERS, 1,2-HEXANEDIOL, ALLANTOIN, TOCOPHERYL ACETATE, XANTHAN GUM, GLYCINE SOJA (SOYBEAN) OIL, SODIUM HYALURONATE, TOCOPHEROL, GLYCOGEN, ETHYLHEXYLGLYCERIN, CAPRYLHYDROXAMIC ACID, SORBITAN ISOSTEARATE, CITRIC ACID, SODIUM HYDROXIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120ml Carton120ml Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60ml Carton60ml Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml Carton30ml Carton

Product Linked Resources#

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
84448-801-12Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50120 mL in 1 TUBECREAM1201
84448-801-12Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 501 in 1 CARTONCREAM11
84448-801-30Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 5030 mL in 1 TUBECREAM301
84448-801-30Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 501 in 1 CARTONCREAM11
84448-801-60Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 501 in 1 CARTONCREAM11
84448-801-60Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 5060 mL in 1 TUBECREAM601

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84448-80184448-801-12, 84448-801-60, 84448-801-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
ndc (package): 84448-801-30
ndc (package): 84448-801-60
ndc (package): 84448-801-12
ndc (product): 84448-801
ndc11 (package): 84448080112
ndc11 (package): 84448080130
ndc11 (package): 84448080160
spl id: 44952d01-7f39-0a9c-e063-6394a90a2018
spl set id: 44952d01-7f38-0a9c-e063-6394a90a2018

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.