CREAM- zinc oxide cream 
Oxygen Development LLC

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 MINERAL SUNSCREEN FACE+BODY FAMILY SIZE

Active ingredient

Zinc Oxide 24%

Purpose

Sunscreen

Uses

Help prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin caused by the sun.

Warnings

For external use only. Do not use on damaged or broken skin.

When using

When using this product keep out of the eyes. rinse with water to remove.

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 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 the 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 am - 2 pm. Wear long-sleeved shirt, pants, hat, and sunglasses. Children under 6 months: ask a doctor

Inactive ingredient

Water/Aqua, 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 the product in this container from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number provided below.

Package label

61354-089-01_aw

CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-089
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.05 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G) 0.9 mg  in 100 mg
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) 0.5 mg  in 100 mg
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 0.5 mg  in 100 mg
WATER (UNII: 059QF0KO0R) 31.495 mg  in 100 mg
STYRENE (UNII: 44LJ2U959V) 2.91 mg  in 100 mg
PROPANEDIOL (UNII: 5965N8W85T) 1.95 mg  in 100 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.5 mg  in 100 mg
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) 2 mg  in 100 mg
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 3 mg  in 100 mg
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) 1.99 mg  in 100 mg
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 1 mg  in 100 mg
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 0.95 mg  in 100 mg
ETHYL MACADAMIATE (UNII: ANA2NCS6V1) 3.99 mg  in 100 mg
C15-19 ALKANE (UNII: CI87N1IM01) 15 mg  in 100 mg
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) 4 mg  in 100 mg
GLYCERIN (UNII: PDC6A3C0OX) 4.98 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-089-011 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/02/2023
Labeler - Oxygen Development LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(61354-089)

Revised: 2/2023
Document Id: f3bb0b9d-bab0-4770-e053-2995a90a9571
Set id: f3bb0b9d-baaf-4770-e053-2995a90a9571
Version: 1
Effective Time: 20230202
 
Oxygen Development LLC