Indications and uses
Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer & early signs of aging caused by the sun.
Squalane plus Mineral SPF 45
- Manufacturer
- Amyris, Inc.
- Effective date
- 2020-02-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:03:51
Label at a glance#
ProductSqualane plus Mineral SPF 45
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure10 sections
Dosage and administration
Apply liberally and evenly to face and neck 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. 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 a broad spectrum value of SPF 15 or higher and other sun protection measu...
Storage and handling
Protect this product from excessive heat and direct sun May stain some fabrics.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients
Titanium Dioxide 4.069%
Zinc Oxide 7%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early signs of aging caused by the sun.
Warnings
- 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 center right away.
Directions
- Apply liberally and evenly to face and neck 15 minutes before sun exposure. Reapply:
- After 80 minutes of swimming or sweating. Immediately after towel drying.
- 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 a broad spectrum value of SPF 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.
Inactive ingredients
Water, Caprylic/Capric Triglyceride, Squalane, Polyglyceryl-3 Sorbityl Linseedate, Cetyl Dimethicone, Dimethicone, Polymethylsilsesquioxane, Glycerin, Styrene/Acrylates Copolymer, Thermus Thermophilus Ferment, Polyhydroxystearic Acid, Synthetic Fluorphlogopite, Sodium Chloride, Hydroxyacetophenone, Tocopheryl Acetate, Saccharide Isomerate, Caramel, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Disteardimonium Hectorite, Triethoxycaprylylsilane, Bisabolol, Benzylidene Dimethoxydimethylindanone, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Zingiber Officinale (Ginger) Root Extract
Other Information
- Protect this product from excessive heat and direct sun
- May stain some fabrics.
Questions or Comments?
Call toll free 1-844-688-5885
PRINCIPAL DISPLAY PANEL - 50 ML Tube Carton
BIOSSANCE
SQUALANE +
MINERAL SPF 45
BROAD SPECTRUM
UVA/UVB FACIAL
SUNSCREEN LOTION
45
Protects, Primes
& Hydrates Face
50ML/1.6907 FL. OZ.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73517-123-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-52f9-a426-e053-dadaa90af4c2 | Squalane plus Mineral SPF 45 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73517-123-01 | Squalane plus Mineral SPF 45 | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 73517-123-01 | Squalane plus Mineral SPF 45 | 50 mL in 1 TUBE | CREAM | 50 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Squalane plus Mineral SPF 45
- Titanium Dioxide and Zinc Oxide
- Titanium Dioxide
- Zinc Oxide
- Water
- Medium-Chain Triglycerides
- Squalane
- Dimethicone
- Polymethylsilsesquioxane (4.5 Microns)
- Glycerin
- STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)
- Thermus Thermophilus Lysate
- POLYHYDROXYSTEARIC ACID (2300 MW)
- Sodium Chloride
- Hydroxyacetophenone
- .Alpha.-Tocopherol Acetate
- Saccharide Isomerate
- Caramel
- Pentylene Glycol
- 1,2-Hexanediol
- Caprylyl Glycol
- Disteardimonium Hectorite
- Triethoxycaprylylsilane
- Levomenol
- Benzylidene Dimethoxydimethylindanone
- Citrus Aurantium Flower
- Ginger
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73517-123 | 73517-123-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f059d98b-bdb6-46ba-91be-4f99f24e4feb | f05a2970-675c-4e7b-9e32-181819f4a23b | 2020-02-25 | Warnings | f059d98b-bdb6-46ba-91be-4f99f24e4feb f05a2970-675c-4e7b-9e32-181819f4a23b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.