Mustela ® Broad spectrum SPF 50+ mineral sunscreen stick

Drug Labeling and Warnings

Drug Details [pdf]

MUSTELA BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN- titanium dioxide and zinc oxide stick 
Expanscience Laboratories d/b/a Mustela

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mustela ® Broad spectrum SPF 50+ mineral sunscreen stick

Drug Facts

Active ingredients	Purpose
Titanium Dioxide 6.0%	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

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 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.

Inactive ingredients

Aluminum Hydroxide, Beeswax, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetyl Alcohol, Dimethicone, Euphorbia Cerifera (Candelilla) Wax, Isostearic Acid, Neopentyl Glycol Diethylhexanoate, Ozokerite, Paraffin, Polyethylene, Stearic Acid, Tocopherol.

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 14.2 g Stick Carton

mustela®

SPF UVA/UVB
50 +
WATER RESISTANT

Broad spectrum SPF 50+
mineral sunscreen stick

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

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

NET WT. 0.5 OZ - 14.2 g

EXPANSCIENCE®
LABORATOIRES

MUSTELA BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN 
titanium dioxide and zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64768-2923
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
CANDELILLA WAX (UNII: WL0328HX19)
ISOSTEARIC ACID (UNII: X33R8U0062)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
CERESIN (UNII: Q1LS2UJO3A)
PARAFFIN (UNII: I9O0E3H2ZE)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64768-2923-1	1 in 1 CARTON	07/01/2015
1		14.2 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/01/2015	08/31/2019

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

Revised: 11/2018

Document Id: 7b0692fd-71dc-bd7d-e053-2a91aa0a3a38

34390-5

Set id: 7e90d784-0875-4856-8c1d-b1bc69a7bddb

Version: 4

Effective Time: 20181119