PIPETTE MINERAL SUNSCREEN BROAD SPECTRUM SPF50- 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 20%

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, Glycerin, Squalane, Cetearyl Alcohol, Methyl Dihydroabietate, Sorbitan Olivate, Cetyl Palmitate, Coco-Glucoside, Ethyl Ferulate, Bisabolol, Hydroxyacetophenone, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylyl/Capryl Glucosides, 1,2-Hexandiol, Caprylyl Glycol, Physalis Angulata Extract, Acacia Senegal Gum, Xanthan Gum, Sodium Gluconate.

Figure

PIPETTE MINERAL SUNSCREEN BROAD SPECTRUM  SPF50
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-382
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 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)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
COCO GLUCOSIDE (UNII: ICS790225B)  
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)  
ACACIA SENEGAL WHOLE (UNII: QP4QYZ033C)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
BISABOLOL OXIDE A (UNII: 16AE65F94Y)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
HEXANEDIOL (UNII: ZIA319275I)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73517-382-01120 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2020
2NDC:73517-382-0230 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2020
3NDC:73517-382-0315 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2020
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: ec975c9d-a14e-db6c-e053-2995a90a9e8f
Set id: a93cd61a-ae83-4c45-8fca-f904b5cf706d
Version: 5
Effective Time: 20221103
 
Amyris, Inc