NENA MINERAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide cream

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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive ingredients:

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

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 swallowed, call a poison control centre or get medical help right away

Directions

Apply liberally and evenly 15 minutes before sun exposure.
Reapply at least every 2 hours.
Children under 6 months of age: Ask a doctor.
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. wear long-sleeved shirts, pants, hats, and sunglasses.

Use a water resistant sunscreen if swimming or sweating.

Drug Facts

Active ingredients (in each dosage unit) Purpose

Titanium dioxide 2.3% ……………………………………………………………………… Sunscreen

Zinc oxide 22% .…………………….………………………………………………………. Sunscreen

Uses

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.

Questions?

Email contact@nenaskincare.com

Other information

Protect the product in this container from excessive heat and direct sun.

DOSAGE & ADMINISTRATION

Dosage: Cream

Route of adminstration: Topical

INDICATIONS & USAGE

See "Uses" and "Warnings"

KEEP OUT OF REACH OF CHILDREN

Refer to "Keep out of reach of children" in "Warnings" section

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NENA MINERAL SUNSCREEN SPF 30 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52311-686
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TOCOPHEROL (UNII: R0ZB2556P8)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PROPANEDIOL (UNII: 5965N8W85T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
UNDECANE (UNII: JV0QT00NUE)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBIC ACID (UNII: X045WJ989B)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
GLYCERIN (UNII: PDC6A3C0OX)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TRIDECANE (UNII: A3LZF0L939)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CHROMIC OXIDE (UNII: X5Z09SU859)
BRASSICA RAPA SUBSP. OLEIFERA WHOLE (UNII: B0MET6L3EC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52311-686-01	1 in 1 BOX	06/17/2024	06/30/2026
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/17/2024	06/30/2026

Labeler - Ironwood Clay Company Inc. (248997694)

Registrant - Ironwood Clay Company Inc. (248997694)

Establishment
Name	Address	ID/FEI	Business Operations
Ironwood Clay Company Inc.		248997694	manufacture(52311-686)