MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

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, Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 24%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed wtih 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 the 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 to exposed areas 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 of 15 or higher and other sun protection measures including:
• limit time in the sun, expecially from 10 a.m. - 2 p.m.
• wear long-sleeved shirt, pants, hat and sunglasses
• children under 6 months: ask a doctor

Inactive ingredients

WATER, C15-19 ALKANE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYL MACADAMIATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STYRENE/ACRYLATES COPOLYMER, STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, SODIUM CHLORIDE, CAPRYLHYDROXAMIC ACID, TOCOPHERYL ACETATE, SODIUM HYALURONATE, TOCOPHEROL, MALIC ACID

Other information

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

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

Mustela

baby - child

MINERAL SUNSCREEN

FACE + BODY

DERMATOLOGIST TESTED

BROAD SPECTRUM

SPF 50

WATER RESISTANT

(80 MINUTES)

FOR BABIES, CHILDREN AND THE ENTIRE FAMILY

SAFE FOR SENSITIVE SKIN TYPES

0% FRAGRANCE AND PARABENS

100ml - 3.38 US FL.OZ.

EXPANSCIENCE LABORATOIRES

INGREDIENTS AND APPEARANCE

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64768-2924
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	240 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
PROPANEDIOL (UNII: 5965N8W85T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MALIC ACID (UNII: 817L1N4CKP)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
C15-19 ALKANE (UNII: CI87N1IM01)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64768-2924-1	100 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(64768-2924)