Label: PROTECT PREVENT DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide cream
- NDC Code(s): 80971-102-01
- Packager: Norwex Usa, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 25, 2023
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- DRUG FACTS
- ACTIVES/MEDICINAL INGREDIENTS:% W/W- P/P:
- USES
- WARNINGS
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DIRECTIONS
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Reapply after 40 minutes of swimming or sweating.
- Reapply immediately after towel drying.
- 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.; and wear long-sleeved shirts, pants, hats and sunglasses.
- Store in a cool dry place.
- Do not use if safety seal is broken.
- May stain some fabric.
- Protect the product in this container from excessive heat and direct sun.
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NON-MEDICINAL/OTHER INGREDIENTS:
Water, Isoamyl Laurate, Caprylic/ Capric Triglyceride, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Arachidyl Alcohol, Polyglyceryl-10 Laurate, Cetearyl Olivate, Lactobacillus Ferment, Sorbitan Olivate, Argania Spinosa (Argan) Kernel Oil, Fructose, Linum Usitatissimum (Flaxseed) Seed Oil*, Ribes Nigrum (Black Currant) Seed Oil*, Rubus Chamaemorus (Cloudberry) Seed Oil*, Withania Somnifera (Ashwagandha) Root Extract, Sambucus Nigra (Elderberry) Seed Oil*, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea (Lingonberry) Seed Oil*, Hippophae Rhamnoides (Sea Buckthorn) Fruit Extract, Betula Alba (Birch Sap Juice) Bark Extract, Ocimum Basilicum (Basil) Oil, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Geranium) Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Hydroxyacetophenone, Biosaccharide Gum-4, Stearic Acid, Bisabolol, Arachidyl Glucoside, Behenyl Alcohol, Polyhydroxystearic Acid, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, Xanthan Gum, 1,2-Hexanediol, Citric Acid, Alumina, Microcrystalline Cellulose, Styrene/Acrylates Copolymer, Potassium Sorbate, Limonene, Linalool, Citral. *Organic Ingredients/ Ingrédients organiques.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
PROTECT PREVENT DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80971-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 28.8 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 68 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOAMYL LAURATE (UNII: M1SLX00M3M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) ARGAN OIL (UNII: 4V59G5UW9X) FRUCTOSE (UNII: 6YSS42VSEV) FLAX SEED (UNII: 4110YT348C) RIBES NIGRUM SEED OIL (UNII: GKE1188837) RUBUS CHAMAEMORUS SEED OIL (UNII: WH495F04LZ) WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) SAMBUCUS NIGRA SEED OIL (UNII: ZZV3NWA4A3) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) LINGONBERRY SEED OIL (UNII: 44P1VFO6KM) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) BETULA PUBESCENS BARK (UNII: 3R504894L9) BASIL OIL (UNII: Z129UMU8LE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LAVENDER OIL (UNII: ZBP1YXW0H8) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) BERGAMOT OIL (UNII: 39W1PKE3JI) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) STEARIC ACID (UNII: 4ELV7Z65AP) LEVOMENOL (UNII: 24WE03BX2T) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) DOCOSANOL (UNII: 9G1OE216XY) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) XANTHAN GUM (UNII: TTV12P4NEE) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALUMINUM OXIDE (UNII: LMI26O6933) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) CITRAL (UNII: T7EU0O9VPP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80971-102-01 1 in 1 CARTON 01/01/2023 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 not final part352 01/01/2023 Labeler - Norwex Usa, Inc. (016707931)
