NENA Mineral Sunscreen SPF 30

NENA Mineral Sunscreen SPF 30 by

Drug Labeling and Warnings

NENA Mineral Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Ironwood Clay Company, Inc., Ironwood Clay Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NENA MINERAL SUNSCREEN SPF 30- zinc oxide,titanium dioxide cream 
Ironwood Clay Company, Inc.

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NENA Mineral Sunscreen SPF 30

Drug Facts

Active Ingredient

Zinc Oxide 22%
Titanium Dioxide 2.3%

Purpose

UVA/UVB protection
Sunburn protectant

Uses

  • Absorbs throughout the UVA/UVB spectrum to provide sunburn protection.
  • Broad spectrum.
  • Filters/Screens UVA/UVB rays.
  • Helps prevent sunburn.
  • Helps protect from sunburn.
  • If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun.
  • Sun Protection Factor 30 / SPF 30.
  • Sunscreen.

Warnings

For external use only
Do not use on broken skin.
When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.If swallowed, call a poison control centre or get medical help right away

Directions


Infants, children, adolescents and adults 0.5 year and older:
Apply liberally/generously (and evenly) 15 minutes before sun exposure.
Reapply 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. / 11 a.m. - 3 p.m.; and wear long-sleeved shirts, pants, hats, and sunglasses.
Use a water resistant sunscreen if swimming or sweating.

Inactive ingredients

Sea Silt Extract, Propanediol, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Undecane, Glycerin, Glyceryl Stearate SE, Tridecane, Myristyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Sea Silt, Aloe Barbadensis Leaf Extract, Xanthan Gum, Brassica Campestris/Aleurites Fordi Oil Copolymer, Jojoba Esters, Calendula Officinalis Flower Extract, Behenyl Alcohol, Arachidyl Glucoside, Camellia Sinensis Leaf Extract,
Tocopherols, Salicylic Acid, Stearyl Alcohol, Myristyl Glucoside, Arachidyl Alcohol, Benzyl Alcohol, Sorbic Acid, Alumina, Chromium Oxide Greens.

Questions?

Email contact@nenaskincare.com

Product Label

image description

NENA MINERAL SUNSCREEN SPF 30 
zinc oxide,titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52311-676
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPANEDIOL (UNII: 5965N8W85T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
UNDECANE (UNII: JV0QT00NUE)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
TRIDECANE (UNII: A3LZF0L939)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BRASSICA RAPA SUBSP. OLEIFERA WHOLE (UNII: B0MET6L3EC)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SORBIC ACID (UNII: X045WJ989B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52311-676-011 in 1 BOX10/01/202310/01/2023
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/01/202310/01/2023
Labeler - Ironwood Clay Company, Inc. (248997694)
Registrant - Ironwood Clay Company, Inc. (248997694)
Establishment
NameAddressID/FEIBusiness Operations
Ironwood Clay Company Inc.248997694manufacture(52311-676)

Revised: 2/2024