MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM- zinc oxide lotion

MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM by

Drug Labeling and Warnings

MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide 12.0015%

PURPOSE

Purpose

Sunscreen

USES

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 cause by the sun

WARNINGS

Warnings

For external use only

Do not useon damaged or broken skin

Stop use and ask a doctor if

• rash or irritation develops and lasts

When using this productkeep out of eyes. Rinse with water to remove.

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

DIRECTIONS

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months of age: ask a doctor

Sun Protection Measures

Spending time in the sun increases you 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 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Water (Aqua), Squalane, Isoamyl Laurate, Butyloctyl Salicylate, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-3 Diisostearate, Methylpropanediol, Isopropyl Isostearate, Niacinamide, Sodium Chloride, Polyglyceryl-6 Polyricinoleate, Silica, Sorbitan Sesquiisostearate, Caprae Lac (Goat Milk), Bifida Ferment Lysate, Milk Protein, Eryngium Alpinum (Blue Thistle) Flower Extract, Carthamus Tinctorius (Safflower) Seed Oil, Sambucus Nigra (Elderberry) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Hydroxyacetophenone, Mica, 1,2-Hexanediol, Caprylyl Glycol, Lauroyl Lysine, Glycerin, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Lactose May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Primary Package- MEDIUM

Secondary Package- MEDIUM

INGREDIENTS AND APPEARANCE

MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.0015 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SQUALANE (UNII: GW89575KF9)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MILK PROTEIN (UNII: AY96EDV46J)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
ERYNGIUM ALPINUM FLOWER (UNII: D381NNL4PD)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOSTEARIC ACID (UNII: X33R8U0062)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
MICA (UNII: V8A1AW0880)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LAUROYL LYSINE (UNII: 113171Q70B)
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GOAT MILK (UNII: XE5K5I4RP7)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
SILICA (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
LACTOSE (UNII: J2B2A4N98G)
IRON OXIDES (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-163-00	1 in 1 CARTON	01/01/2024
1		30 mg 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 Drug	M020	01/01/2024

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-163)