MINU BRIGHTENING SUNSCREEN MINERALS SPF 30- titanium dioxide and zinc oxide cream

Minu Brightening Sunscreen Minerals SPF 30 by

Drug Labeling and Warnings

Minu Brightening Sunscreen Minerals SPF 30 by is a Otc medication manufactured, distributed, or labeled by MINU, Weckerle Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 0.5%,	Sunscreen
Zinc Oxide 18.5%	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 and evenly 15 minutes before sun exposure.
• Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours. Children under 6 months of age: Ask a doctor.

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

• Protect this product from excessive heat and direct sun.
• May stain some fabrics.
• Protect from freezing.

Inactive Ingredients

Water, C15-19 Alkane, Cetyl Dimethicone, Phenyl Trimethicone, Caprylic/Capric Triglyceride, Glyceryl Oleate Citrate, Propanediol, Silica, Dimethicone, Glyceryl Dibehenate, Cetearyl Alcohol, Tribehenin, Polyhydroxystearic Acid, Mica, Hydroxyacetophenone, Magnesium Aluminum Silicate, Cetyl Palmitate, Disteardimonium Hectorite, Sorbitan Palmitate, Xanthan Gum, 1,2 Hexanediol, Caprylyl Glycol, Glyceryl Behenate, Polyglyceryl-4 Oleate, Acrylates/Dimethicone Copolymer, Sorbitan Oleate, Synthetic Fluorphlogopite, Cetearyl Glucoside, Triethyl Citrate, Glycerin, Bisabolol, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Stearic Acid, Echinacea Purpurea Extract, Carnosine, Niacinamide, Panthenol, Allantoin, Citric Acid, Sodium Citrate, Tocopheryl Acetate, Polygonum Aviculare Extract, Tropolone, Zingiber Officinale Root Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77499, CI 77491, CI 77492).

Questions?

Contact us at hello@minuskincare.com

SPL UNCLASSIFIED SECTION

Dist. By Minu Inc.
L.A., CA 90274

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton

Brightening
Sunscreen Minerals

Broad Spectrum SPF 30
Gel-Cream

MINU

Dermatologist developed
PA++++
Water resistant (40 min)

50 ML / 1.7 FL OZ

INGREDIENTS AND APPEARANCE

MINU BRIGHTENING SUNSCREEN MINERALS SPF 30 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84184-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	185 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C15-19 ALKANE (UNII: CI87N1IM01)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
MICA (UNII: V8A1AW0880)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
GLYCERIN (UNII: PDC6A3C0OX)
LEVOMENOL (UNII: 24WE03BX2T)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)
ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98)
CARNOSINE (UNII: 8HO6PVN24W)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
TROPOLONE (UNII: 7L6DL16P1T)
GINGER (UNII: C5529G5JPQ)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84184-001-01	1 in 1 CARTON	02/01/2024
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	02/01/2024

Labeler - MINU (119189388)

Establishment
Name	Address	ID/FEI	Business Operations
Weckerle Cosmetics		152060273	MANUFACTURE(84184-001)