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NDC 73517-0128-01 Pipette Mineral Sunscreen Broad Spectrum SPF 50 200 mg/mL Details

Pipette Mineral Sunscreen Broad Spectrum SPF 50 200 mg/mL

Pipette Mineral Sunscreen Broad Spectrum SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Amyris, Inc. The primary component is ZINC OXIDE.

Product Information

NDC	73517-0128
Product ID	73517-128_d5056504-487d-c99e-e053-2a95a90a84ed
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Pipette Mineral Sunscreen Broad Spectrum SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/mL
Substance Name	ZINC OXIDE
Labeler Name	Amyris, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73517-0128-01 (73517012801)

Pricing Information	N/A
NDC Package Code	73517-128-01
Billing NDC	73517012801
Package	120 mL in 1 BOTTLE (73517-128-01)
Marketing Start Date	2020-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b08f641b-49a2-5a90-e053-2a95a90aa860 Details

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

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Amyris, Inc (185930182)

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

Revised: 1/2022

Document Id: d5056504-487d-c99e-e053-2a95a90a84ed

Set id: b08f641b-49a2-5a90-e053-2a95a90aa860

Version: 2

Effective Time: 20220107