SQUALANE PLUS MINERAL SPF 45- titanium dioxide and zinc oxide cream

Squalane plus Mineral SPF 45 by

Drug Labeling and Warnings

Squalane plus Mineral SPF 45 by is a Otc medication manufactured, distributed, or labeled by Amyris, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

• 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.

INGREDIENTS AND APPEARANCE

SQUALANE PLUS MINERAL SPF 45 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73517-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	40.69 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73517-123-01	1 in 1 CARTON	03/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	03/01/2018

Labeler - Amyris, Inc. (185930182)