PIPETTE MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

Pipette Mineral Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Pipette Mineral Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Amyris, Inc, Elevation Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Zinc Oxide 20% Purpose: Sunscreen

Purpose

Sunscreen Helps prevent sunburn

Use

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

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 swallowed get medical help or contact Poison Control Center right away

Directions

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, 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.

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

Inactive Ingredients: Water, Caprylic/Capric Triglyceride, Squalane, Glycerin, Cetearyl Alcohol, Methyl Dihydroabietate, Sorbitan Olivate, Cetyl Palmitate, Coco-Glucoside, Ethyl Ferulate, Caprylyl/Capryl Glucoside, Lecithin, Bisabolol, Physalis Angulata Extract, Xanthan Gum, Acacia Senegal Gum, Sodium Gluconate, Isostearic Acid, Polyhydroxystearic Acid, 1,2-Hexanediol, Polyglyceryl-3 Polyricinoleate, Hydroxyacetophenone, Caprylyl Glycol

Package Label - Principal Display Panel

120 mL NDC: 73517-128-01

INGREDIENTS AND APPEARANCE

PIPETTE MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73517-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM GLUCONATE (UNII: R6Q3791S76)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
ACACIA (UNII: 5C5403N26O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
ETHYL FERULATE (UNII: 5B8915UELW)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
XANTHAN GUM (UNII: TTV12P4NEE)
ISOSTEARIC ACID (UNII: X33R8U0062)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73517-128-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/15/2020

Labeler - Amyris, Inc (185930182)

Establishment
Name	Address	ID/FEI	Business Operations
Elevation Labs		929572014	manufacture(73517-128)