BIOSSANCE SQUALANE MOISTURIZER SPF30- zinc oxide lotion 
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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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

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.

Figure

BIOSSANCE SQUALANE MOISTURIZER  SPF30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-381
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION14 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73517-381-011 in 1 CARTON06/01/2020
120 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:73517-381-021 in 1 CARTON06/01/2020
250 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
3NDC:73517-381-031 in 1 CARTON06/01/2020
3100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02006/01/2020
Labeler - Amyris, Inc (185930182)

Revised: 11/2022
Document Id: ec976a81-09f3-6fb6-e053-2995a90a46e2
Set id: ee62c442-742f-44e9-b58b-e3d901bc9555
Version: 4
Effective Time: 20221103
 
Amyris, Inc