MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide, titanium dioxide spray

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by Expanscience Laboratories d/b/a Mustela. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium Dioxide 4.3%

Zinc Oxide 14.7%

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

• Do not store at temperature above 120F.
• Contents under pressure. Do not puncture or incinerate can.
• Avoid using on children under 3
• For external use only. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

Do not use

on damaged or broken skin

When using this product

keep away from face to avoid breathing it. 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 a product is swallowed get medical help or contact a Poison Control center right away.

Directions

• Shake well before use
• Hold container 4 to 6 inches from the skin to apply
• Apply liberally 15 minutes before sun exposure
• Do not spray directly into face
• Do not spray in windy condition
• Use in well-ventilated area
• 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 of 15 or higher and other protection measures including:
• Limit time in the sun, especially from 10 a.m - 2p.m
• Wear long-sleeved shirt, pants, hat, and sunglasses
• Children under 6 months: ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.
• You may report a serious adverse event to the phone number or address provided below.
• May stain some fabrics.

Inactive ingredients

Water, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydroabietate, Cetearyl Alcohol, Propanediol, Sodium Stearoyl Glutamate, Bentonite, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Bisabolol*, Alumina, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Silica, Cellulose Gum, Aloe Barbadensis Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Spiraea Ulmaria Flower Extract*, Nasturtium Officinale Flower/Leaf Extract*, *Certified Organic Ingredients

Questions or comments?

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

Company Information

MADE IN THE USA from globally sourced materials for
Expanscience Laboratories Inc.,
Dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022
www.MustelaUSA.com

Product Packaging

INGREDIENTS AND APPEARANCE

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
zinc oxide, titanium dioxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64768-2927
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	147 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BENTONITE (UNII: A3N5ZCN45C)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO GLUCOSIDE (UNII: ICS790225B)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CHAMOMILE (UNII: FGL3685T2X)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LEVOMENOL (UNII: 24WE03BX2T)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
SUNFLOWER OIL (UNII: 3W1JG795YI)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT OIL (UNII: Q9L0O73W7L)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64768-2927-1	170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2021

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