MICRO DAY REJUVENATING BROAD-SPECTRUM SUNSCREEN SPF 30- octinoxate and zinc oxide lotion

Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Merz North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%

Zinc Oxide 7.3%

Purpose

Sunscreen

Uses

• Helps prevent sunburn and premature skin aging.
• 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.
• Higher SPF gives more sunburn protection.

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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

See package insert for complete information.

DOSAGE & ADMINISTRATION

For sunscreen use:

• Apply generously 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 Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10am - 2pm
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months of age, ask a doctor.

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Hydrogenated C6-14 Olefin Polymers, Hexyldecanol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Camelia Sinensis Extract, Silica, Tetrapeptide-21, Capryloyl Carnosine, Palmitoyl Tripeptide-1 Acetate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Squalane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyhydroxystearic Acid, Steareth-21, Melanin, Cetearyl Alcohol, Sodium Hyaluronate, Polysorbate 60, Triethoxycaprylsilane, Disodium EDTA, Xanthan Gum, Cellulose Gum, Styrene/Acrylates Copolymer, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben.

Other information

• Protect this product from excessive heat and direct sun.

Questions?

USA: 866.636.2884 International: +800.1489.1489

SPL UNCLASSIFIED SECTION

Distributed in the USA by Merz North America, Inc.

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton

micro day®

REVITALIZING
& TIGHTENING
DAY CREAM
SPF 30

NEOCUTIS®

INGREDIENTS AND APPEARANCE

MICRO DAY REJUVENATING BROAD-SPECTRUM SUNSCREEN SPF 30 
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46783-173
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HEXYLDECANOL (UNII: 151Z7P1317)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-21 (UNII: 53J3F32P58)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46783-173-05	1 in 1 CARTON	03/23/2015
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 46783-173-10	1 in 1 CARTON	03/23/2015
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 46783-173-20	1 in 1 CARTON	03/23/2015
3		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 46783-173-04	4 mL in 1 TUBE; Type 0: Not a Combination Product	06/15/2019
5	NDC: 46783-173-50	1 in 1 CARTON	10/20/2019
5		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	03/23/2015

Labeler - Merz North America, Inc. (028147846)