SQUALANE PLUS MINERAL SPF 45- titanium dioxide and zinc oxide cream 
Amyris, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Squalane plus Mineral SPF 45

Drug Facts

Active Ingredients

Titanium Dioxide 4.069%
Zinc Oxide 7%

Purpose

Sunscreen

Uses

Warnings

  • Do not use on damaged or broken skin.

  • Stop use and ask a doctor if rash occurs.

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

  • Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

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

Questions or Comments?

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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.

PRINCIPAL DISPLAY PANEL - 50 ML Tube Carton
SQUALANE PLUS MINERAL SPF 45 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40.69 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Squalane (UNII: GW89575KF9)  
Dimethicone (UNII: 92RU3N3Y1O)  
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
Glycerin (UNII: PDC6A3C0OX)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
Thermus Thermophilus Lysate (UNII: 775R692494)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Sodium Chloride (UNII: 451W47IQ8X)  
Hydroxyacetophenone (UNII: G1L3HT4CMH)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Saccharide Isomerate (UNII: W8K377W98I)  
Caramel (UNII: T9D99G2B1R)  
Pentylene Glycol (UNII: 50C1307PZG)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Levomenol (UNII: 24WE03BX2T)  
Benzylidene Dimethoxydimethylindanone (UNII: 75HIF3C97L)  
Citrus Aurantium Flower (UNII: O730ZX2Z83)  
Ginger (UNII: C5529G5JPQ)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73517-123-011 in 1 CARTON03/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/01/2018
Labeler - Amyris, Inc. (185930182)

Revised: 2/2020
Document Id: f059d98b-bdb6-46ba-91be-4f99f24e4feb
Set id: f05a2970-675c-4e7b-9e32-181819f4a23b
Version: 1
Effective Time: 20200225
 
Amyris, Inc.