Active Ingredient
Zinc Oxide 24%
Mustela Mineral Sunscreen Broad Spectrum Spf 50 Lotion
FDA Label NDC 64768-2924
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Expanscience Laboratories D/b/a Mustela for the product Mustela Mineral Sunscreen Broad Spectrum Spf 50 (NDC 64768-2924). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of the eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
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
* Please review the disclaimer below.
