Label: NENA MINERAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide cream
- NDC Code(s): 52311-686-01
- Packager: Ironwood Clay Company Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 5, 2024
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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
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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.
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INGREDIENTS AND APPEARANCE
NENA MINERAL SUNSCREEN SPF 30
titanium dioxide, zinc oxide creamProduct 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 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 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)