DailyMed - MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

NDC Code(s): 64768-2924-1, 64768-2924-2, 64768-2924-3
Packager: Expanscience Laboratories d/b/a Mustela

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated June 2, 2025

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Drug Facts

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Active Ingredient
Zinc Oxide 24%

Zinc Oxide 24%
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Purpose
Sunscreen

Sunscreen
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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.
- 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.
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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 ...

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.

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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 ...
- 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
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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.
- 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.
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Inactive ingredients
WATER, C15-19 ALKANE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYL MACADAMIATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STYRENE/ACRYLATES COPOLYMER, STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER, LAURYL ...

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

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

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
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Product Packaging - 100ml

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INGREDIENTS AND APPEARANCE

Product Information

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

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

Ingredient Name	Strength
Inactive Ingredients
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)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64768-2924-1	100 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2019
2	NDC:64768-2924-2	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020	10/23/2023
3	NDC:64768-2924-3	325 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/07/2022	11/30/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/01/2019

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

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Published Date (What is this?)	Version	Files
Jun 4, 2025	6 (current)	download
Dec 4, 2024	5	download
Oct 24, 2023	4	download
Mar 9, 2022	3	download
Apr 28, 2020	2	download
Nov 1, 2019	1	download

Label: MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

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	NDC
1	64768-2924-1
2	64768-2924-2
3	64768-2924-3

Label: MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

View Package Photos

Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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Safety

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More Info on this Drug

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

Number of versions: 6

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

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MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.