Label: NORWEX PROTECT PREVENT MINERAL FACIAL SUNSCREEN BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide lotion
- NDC Code(s): 68577-158-01
- Packager: COSMAX USA, CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 24, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- Warnings
-
DIRECTIONS
Directions
- apply generously 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.
- 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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INACTIVE INGREDIENT
Inactive 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, Hydroxy[1]acetophenone, Biosaccharide Gum-4, Stearic Acid, Bisabolol, Arachidyl Glucoside, Behenyl Alcohol, Poly[1]hydroxystearic 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.
- OTHER INFORMATION
- QUESTIONS or COMMENTS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NORWEX PROTECT PREVENT MINERAL FACIAL SUNSCREEN BROAD SPECTRUM SPF30
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68577-158 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.88 mg in 100 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.8 mg in 100 mg Inactive Ingredients Ingredient Name Strength LEMON OIL (UNII: I9GRO824LL) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) DOCOSANOL (UNII: 9G1OE216XY) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ALUMINUM OXIDE (UNII: LMI26O6933) LIMONENE, (+/-)- (UNII: 9MC3I34447) LINALOOL, (+/-)- (UNII: D81QY6I88E) CITRAL (UNII: T7EU0O9VPP) ORANGE OIL (UNII: AKN3KSD11B) HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77) 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) LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) SORBITAN OLIVATE (UNII: MDL271E3GR) ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H) FRUCTOSE (UNII: 6YSS42VSEV) LINSEED OIL (UNII: 84XB4DV00W) RIBES NIGRUM SEED OIL (UNII: GKE1188837) RUBUS CHAMAEMORUS SEED OIL (UNII: WH495F04LZ) 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) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) BERGAMOT OIL (UNII: 39W1PKE3JI) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) LEVOMENOL (UNII: 24WE03BX2T) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68577-158-01 1 in 1 CARTON 09/01/2023 1 50 mg 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 09/01/2023 Labeler - COSMAX USA, CORPORATION (010990210) Registrant - COSMAX USA, CORPORATION (010990210) Establishment Name Address ID/FEI Business Operations COSMAX USA. CORPORATION 010990210 manufacture(68577-158)
