Mustela broad spectrum spf 50 plus mineral sunscreen lotion

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

Active ingredients Purpose
Titanium Dioxide 4.9% Sunscreen
Zinc Oxide 4.7% 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

Otc - do not use section

Do not useon damaged or broken skin.

Otc - when using section

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

Otc - stop use section

Stop use and ask a doctorif rash occurs.

Otc - keep out of reach of children section

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

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • after 40 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 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
  • children under 6 months: Ask a doctor

Other information

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

Inactive ingredients

1,2-Hexanediol, Alumina, Arachidyl Alcohol, Arachidyl Glucoside, Ascorbic Acid, Avena Sativa (Oat) Kernel Extract, Beeswax, Behenyl Alcohol, Bisabolol, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Dimethicone, Dimethicone PEG-8 Laurate, Dipotassium Glycyrrhizate, Disodium EDTA, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Isostearic Acid, Methicone, Methylisothiazolinone, PEG-100 Stearate, PEG-8, Pentylene Glycol, Polyhydroxystearic Acid, Polymethyl Methacrylate, Polysorbate 60, Potassium Sorbate, Silica, Stearic Acid, Styrene/ Acrylates Copolymer, Tocopherol, Tocopheryl Acetate, Trimethylsiloxysilicate, Trisiloxane, Water, Xanthan Gum.

Questions or comments?

Call toll free 1-800-422-2987
Monday-Friday 9:00am 5:00pm EST

Ingredients and appearance - Product information

Mustela broad spectrum spf 50 plus mineral sunscreen lotion- Titanium dioxide and zinc oxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 64768-2921
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Titanium dioxide ( UNII: 15FIX9V2JP)( Titanium dioxide - UNII: 15FIX9V2JP ) 4.9 gin 100 g
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 4.7 gin 100 g

Inactive Ingredients

Ingredient Name Code
1,2-hexanediol ( UNII: TR046Y3K1G)
Aluminum oxide ( UNII: LMI26O6933)
Arachidyl alcohol ( UNII: 1QR1QRA9BU)
Arachidyl glucoside ( UNII: 6JVW35JOOJ)
Ascorbic acid ( UNII: PQ6CK8PD0R)
Oat ( UNII: Z6J799EAJK)
Yellow wax ( UNII: 2ZA36H0S2V)
Docosanol ( UNII: 9G1OE216XY)
Levomenol ( UNII: 24WE03BX2T)
Butylene glycol ( UNII: 3XUS85K0RA)
Butyloctyl salicylate ( UNII: 2EH13UN8D3)
Alkyl (c12-15) benzoate ( UNII: A9EJ3J61HQ)
Caprylyl glycol ( UNII: 00YIU5438U)
Cetyl dimethicone 25 ( UNII: U4AS1BW4ZB)
Dimethicone ( UNII: 92RU3N3Y1O)
Dimethicone peg-8 laurate ( UNII: 72MF9C2A18)
Glycyrrhizinate dipotassium ( UNII: CA2Y0FE3FX)
Edetate disodium ( UNII: 7FLD91C86K)
Glycerin ( UNII: PDC6A3C0OX)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) ( UNII: 86FQE96TZ4)
Isohexadecane ( UNII: 918X1OUF1E)
Isostearic acid ( UNII: X33R8U0062)
Methicone (20 cst) ( UNII: 6777U11MKT)
Methylisothiazolinone ( UNII: 229D0E1QFA)
Peg-100 stearate ( UNII: YD01N1999R)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Pentylene glycol ( UNII: 50C1307PZG)
Polyhydroxystearic acid (2300 mw) ( UNII: YXH47AOU0F)
Poly(methyl methacrylate; 450000 mw) ( UNII: Z47NNT4J11)
Polysorbate 60 ( UNII: CAL22UVI4M)
Potassium sorbate ( UNII: 1VPU26JZZ4)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Stearic acid ( UNII: 4ELV7Z65AP)
Styrene/acrylamide copolymer (mw 500000) ( UNII: 5Z4DPO246A)
Tocopherol ( UNII: R0ZB2556P8)
.alpha.-tocopherol acetate ( UNII: 9E8X80D2L0)
Trimethylsiloxysilicate (m/q 0.6-0.8) ( UNII: 5041RX63GN)
Trisiloxane ( UNII: 9G1ZW13R0G)
Water ( UNII: 059QF0KO0R)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color WHITE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part352 USA

Labeler - Expanscience Laboratories d/b/a Mustela( 181191057)

Establishment

Name ID/FEI Business Operations
Expanscience Laboratories d/b/a Mustela 181191057 MANUFACTURE( 64768-2921)

Principal display panel - 100 ml tube label

Mustela ®

50+
SPF
UVB / UVA

Broad spectrum SPF 50+
mineral sunscreen lotion

  • Water-resistant (40 minutes)
  • 100% mineral based active ingredients

HYPOALLERGENIC HIGH TOLERANCE
0% PARABEN, 0% FRAGRANCE, 0% PHENOXYETHANOL
TESTED UNDER DERMATOLOGICAL AND PEDIATRIC CONTROL

e100 ml - 3.4 US FL. OZ

EXPANSCIENCE ®
LABORATOIRES