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NDC 72203-0017-01 Perfect Sunscreen Tinted Mineral SPF50 0.12 g/mL Details

Perfect Sunscreen Tinted Mineral SPF50 0.12 g/mL

Perfect Sunscreen Tinted Mineral SPF50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Bluemercury, Inc.. The primary component is ZINC OXIDE.

Product Information

NDC	72203-0017
Product ID	72203-017_41b075a5-cb84-4909-82d0-d4e68e250482
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	Perfect Sunscreen Tinted Mineral SPF50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	0.12
Active Ingredient Units	g/mL
Substance Name	ZINC OXIDE
Labeler Name	Bluemercury, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72203-0017-01 (72203001701)

Pricing Information	N/A
NDC Package Code	72203-017-01
Billing NDC	72203001701
Package	1 BOTTLE in 1 CARTON (72203-017-01) / 50 mL in 1 BOTTLE
Marketing Start Date	2022-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4c978154-679f-472a-95ab-56878c5c70cd Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 12%

Purpose

sunscreen

Uses

Helps prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
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 SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am-2pm.
- Wear long-sleeve shirts, pants, hats & sunglasses.
Children under 6 months of age: Ask a doctor.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Squalane, Isoamyl Laurate, Butyloctyl Salicylate, Glycerin, Jojoba Esters, Methylpropanediol, Cetyl Alcohol, Glyceryl Stearate, Silica, Tocopherol, Tocopheryl Acetate, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Lavandula Angustifolia (Lavender) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, Pyrus Malus (Apple) Fruit Extract, Allantoin, Bisabolol, Lecithin, Lysolecithin, Caprylyl Glycol, Sclerotium Gum, Phenylpropanol, Pullulan, Xanthan Gum, Polyglyceryl-2 Dipolyhydroxystearate, Ceteth-20, Steareth-20, Tetrasodium Glutamate Diacetate, Phenoxyethanol, PEG-75 Stearate, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide

Other Information

Protect the product in this container from excessive heat and direct sun.

Questions?

800-294-7700 9-5pm EST, Monday-Friday

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

m-61®

powerful skincare

Perfect

Sunscreen

SPF 50

Sheer Mineral

BROAD SPECTRUM SPF 50

VITAMIN E AND GREEN TEA

REEF SAFE MINERAL

SUNSCREEN

Sheer mineral SPF 50 with

vitamin E, green tea, lavender

and plant-derived squalane

all skin types

100% paraben-free

100% synthetic fragrance-free

dermatologist tested

allergy tested

50 mL/ 1.7 FL. OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

INGREDIENTS AND APPEARANCE

PERFECT SUNSCREEN TINTED MINERAL SPF50

zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72203-017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.12 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Medium-chain Triglycerides (UNII: C9H2L21V7U)
Squalane (UNII: GW89575KF9)
Isoamyl Laurate (UNII: M1SLX00M3M)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Glycerin (UNII: PDC6A3C0OX)
Methylpropanediol (UNII: N8F53B3R4R)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Tocopherol (UNII: R0ZB2556P8)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Lavandula Angustifolia Subsp. Angustifolia Flowering Top (UNII: 9YT4B71U8P)
Lavandula Angustifolia Subsp. Angustifolia Flower (UNII: 19AH1RAF4M)
Sunflower Oil (UNII: 3W1JG795YI)
Apple (UNII: B423VGH5S9)
Allantoin (UNII: 344S277G0Z)
Levomenol (UNII: 24WE03BX2T)
Caprylyl Glycol (UNII: 00YIU5438U)
Betasizofiran (UNII: 2X51AD1X3T)
Phenylpropanol (UNII: 0F897O3O4M)
Pullulan (UNII: 8ZQ0AYU1TT)
Xanthan Gum (UNII: TTV12P4NEE)
Polyglyceryl-2 Dipolyhydroxystearate (UNII: 9229XJ4V12)
Ceteth-20 (UNII: I835H2IHHX)
Steareth-20 (UNII: L0Q8IK9E08)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
Phenoxyethanol (UNII: HIE492ZZ3T)
PEG-75 Stearate (UNII: OT38R0N74H)
Ethylhexylglycerin (UNII: 147D247K3P)
Hexylene Glycol (UNII: KEH0A3F75J)
Sodium Hydroxide (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72203-017-01	1 in 1 CARTON	04/15/2022
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/15/2022

Labeler - Bluemercury, Inc. (097435361)

Name	Address	ID/FEI	Business Operations
Establishment
Nanophase Technologies		623502044	MANUFACTURE(72203-017)

Revised: 3/2022

Document Id: 41b075a5-cb84-4909-82d0-d4e68e250482

Set id: 4c978154-679f-472a-95ab-56878c5c70cd

Version: 1

Effective Time: 20220317