BIOSSANCE SQUALANE MOISTURIZER SPF30- zinc oxide lotion

Biossance Squalane Moisturizer by

Drug Labeling and Warnings

Biossance Squalane Moisturizer by is a Otc medication manufactured, distributed, or labeled by Amyris, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 14%

Purpose

Sunscreen

Uses

Helps prevent sunburn

if used as directed with other sun protection measures(see ​directions)​, decreases the risk of skkin cancer and early signs of aging caused by the sun.

Warnings

  For external use only

Do not use

on damaged of broken skin

When using this product

keep out of eyes.  Rinse with water to remove

Stop use and ask

a doctor if rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

•  Apply generously 15 minutes before sun exposure
• 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, regularyly 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 shiirts, pants, hats and sunglasses
• use a water-resistant sunscreen if swimming or sweating
• children under 6 months of age:ask a doctor.

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Zinc Oxide, Glycerin, Squalane, Cetearyl Alcohol, Methyl Dihydroabietate, Dipropylene Glycol, Sorbitan Olivate, Cetyl Palmitate, Coco Glucoside, Phenoxyethanol, Sodium Palmitoyl Proline, Ethyl Ferulate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylyl/Capryl Glucosides, Butylene Glycol, Nymphaea Alba Flower Extract, Ethylhexylglycerin, Acacia Senegal Gum, Xanthan Gum, Sodium Gluconate, Glucose.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOSSANCE SQUALANE MOISTURIZER  SPF30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73517-381
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
COCO GLUCOSIDE (UNII: ICS790225B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
ETHYL FERULATE (UNII: 5B8915UELW)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACACIA SENEGAL WHOLE (UNII: QP4QYZ033C)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73517-381-01	1 in 1 CARTON	06/01/2020
1		20 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 73517-381-02	1 in 1 CARTON	06/01/2020
2		50 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
3	NDC: 73517-381-03	1 in 1 CARTON	06/01/2020
3		100 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	M020	06/01/2020

Labeler - Amyris, Inc (185930182)