SQUALANE ZINC SHEER MINERAL SUNSCREEN- squalane zinc sheer mineral sunscreen 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.

----------

SQUALANE + ZINC SHEER MINERAL SUNSCREEN

Secondary

Purpose

Zinc Oxide 14% Sunscreen

Uses
Warnings
Directions

Helps prevent sunburn

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

Warnings

For external use only

Do not use on damaged or 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 swallwed get medical help or contact Poison Control Center right away

Directions

apply generously 15 minutes before sun exposure. reapply at least every 2 hours

Sun Protection Measures

Spendign 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 protections measures including: limit time in the sun, especially from 10 am - 2pm

wear long-sleeved shirts, pants, hats, and sunglasses

use a water resistant sunscreen if swimming or sweating

children under 6 months of age ask a doctor.

Inactive Ingredients:

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

Other Information

protect this product from excessive heat and direct sun

50 mL NDC 73517-125-01

secondary

SQUALANE ZINC SHEER MINERAL SUNSCREEN 
squalane zinc sheer mineral sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE140 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
XANTHAN GUM (UNII: TTV12P4NEE)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
COCO GLUCOSIDE (UNII: ICS790225B)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
SQUALANE (UNII: GW89575KF9)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYL FERULATE (UNII: 5B8915UELW)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ACACIA (UNII: 5C5403N26O)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73517-125-0150 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
Labeler - Amyris, Inc (185930182)

Revised: 1/2022
Document Id: d509651b-4af5-8ae8-e053-2a95a90a042a
Set id: a525b24e-4ced-d47a-e053-2a95a90ad678
Version: 3
Effective Time: 20220107
 
Amyris, Inc