MICRO DAY RICHE- zinc oxide and octinoxate cream

MICRO DAY RICHE by

Drug Labeling and Warnings

MICRO DAY RICHE by is a Otc medication manufactured, distributed, or labeled by Merz North America. 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. If swallowed, get medical help or contact a Poison Control Center right away.

See package insert for complete information.

Directions

• 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

Aqua (Water, Eau), Hydrogenated Polyisobutene, Petrolatum, Caprylic/Capric Triglyceride, Hexyldecanol, Isododecane, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Dioscorea Villosa (Wild Yam) Root Extract, Camellia Sinensis Leaf Extract, Silica, Tetrapeptide-21, Capryloyl Carnosine, Palmitoyl Tripeptide-1 Acetate, Tocopheryl Acetate, Squalene, Sodium Hyaluronate, Cetearyl Alcohol, Steareth-21, Styrene/Acrylates Copolymer, Polysorbate 60, Butylene Glycol, Polysilicone-11, Xanthan Gum, Melanin, Sodium Ascorbyl Phosphate, Cellulose Gum, Disodium EDTA, Sorbitan Isostearate, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben.

Other information

• Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton

MICROESSENTIALS

MICRODAY
RICHE
Rejuvenating Balm
Broad-spectrum
Sunscreen SPF 30

NEO

Powered by
MPC™

NEOCUTIS

Exlusive Swiss Technology
available through physicians

0.5 FL. OZ. (15 ML)

INGREDIENTS AND APPEARANCE

MICRO DAY RICHE 
zinc oxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46783-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	73 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PETROLATUM (UNII: 4T6H12BN9U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HEXYLDECANOL (UNII: 151Z7P1317)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TETRAPEPTIDE-21 (UNII: 179JUC43HU)
CAPRYLOYL SARCOSINE (UNII: BRL7HMB08G)
PALMITOYL TRIPEPTIDE-1 ACETATE (UNII: 99B84UAK70)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SQUALENE (UNII: 7QWM220FJH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-21 (UNII: 53J3F32P58)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
XANTHAN GUM (UNII: TTV12P4NEE)
MELAMINE (UNII: N3GP2YSD88)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46783-275-15	1 in 1 CARTON	01/31/2019
1		15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 46783-275-50	1 in 1 CARTON	01/31/2019
2		50 mL in 1 TUBE; 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	01/31/2019

Labeler - Merz North America (028147846)