VICHY LABORATOIRES MINERAL 89 BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene cream

Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L’Oreal USA Products Inc, Cosmetique Active Production. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

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

For sunscreen use:

• shake well before use

●  apply liberally 15 minutes before sun exposure

●  reapply:

    ●  after 80 minutes of swimming or sweating

    ●  immediately after towel drying

    ●  at least every 2 hours

● 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 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

●  children under 6 months of age: Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun
• store at 68 – 77° F (20 – 25°C)

Inactive ingredients

water, glycerin, silica, propanediol, dimethicone, niacinamide, alcohol denat., titanium dioxide, glyceryl stearate, PEG-100 stearate, mica, tranexamic acid, stearic acid, palmitic acid,ammonium polyacryloyldimethyl taurate, squalene, hydroxyacetophenone, dicaprylyl carbonate, steareth-100, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, citric acid, butylene glycol, synthetic fluorphlogopite, trisodium ethylenediamine disuccinate, tocopherol, sodium hyaluronate, myristic acid, tin oxide, mineral salts

Questions or comments?

Call toll free 1-877-378-4249

Monday - Friday (9 a.m. to 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VICHY LABORATOIRES MINERAL 89 BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-917
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	72 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
PEG-100 STEARATE (UNII: YD01N1999R)
MICA (UNII: V8A1AW0880)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
SQUALANE (UNII: GW89575KF9)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STEARETH-100 (UNII: 4OH5W9UM87)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MYRISTIC ACID (UNII: 0I3V7S25AW)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-917-01	1 in 1 CARTON	07/01/2024
1		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 Drug	M020	07/01/2024

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(49967-917) , pack(49967-917)