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, Rutin, Lecithin, Hydrogenated Lecithin, Lysolecithin, Caprylyl Glycol, Sclerotium Gum, Iron Oxides, Phenylpropanol, Pullulan, Xanthan Gum, C12-15 Alkyl Benzoate, Polyglyceryl-4 Diisostearate/Polyhydroxystearat e/Sebacate, 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

Tinted Mineral

BROAD SPECTRUM SPF 50
VITAMIN E AND GREEN TEA
TINTED REEF SAFE MINERAL
SUNSCREEN

Tinted 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

PERFECT SUNSCREEN SPF 50 SHEER MINERAL
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72203-016
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)
Rutin (UNII: 5G06TVY3R7)
Caprylyl Glycol (UNII: 00YIU5438U)
Betasizofiran (UNII: 2X51AD1X3T)
Ferric Oxide Red (UNII: 1K09F3G675)
Phenylpropanol (UNII: 0F897O3O4M)
Pullulan (UNII: 8ZQ0AYU1TT)
Xanthan Gum (UNII: TTV12P4NEE)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate (UNII: 687U3PEB2Y)
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	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72203-016-01	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(72203-016)

Perfect Sunscreen SPF 50 Tinted Mineral