Label: IMAGE SKINCARE PREVENTION PLUS DAILY HYDRATING MOISTURIZER- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 79458-001-00 - Packager: Natural Technology, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 17, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Zinc Oxide 17.1%. Purpose: Sunscreen
- Purpose: Sunscreen
- Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- 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, get medical help or contact a Poison Control Center right away.
- Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating: Immediately after towel drying. 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 10am to 2pm. Wear long-sleeved shirts, pants, hats and sunglasses.
- Protect the product in this container from excessive heat and direct sun.
- Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Dicaprylyl Carbonate, Glycerin, Aqua/Water/Eau, Alcohol Denat. (SD Alcohol 40-B), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Hydrated Silica, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Isohexadecane, Magnesium Sulfate, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Ricinus Communis (Castor) Seed Oil, Limonene, Caprylic Acid, Caprylic/Capric Triglyceride, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Peel Extract, Lecithin, Propanediol, Orbignya Phalerata Seed Powder, Lauric Acid, Calendula Officinalis Flower Extract, Citrus Limon (Lemon) Peel Extract, Citrus Tangerina (Tangerine) Peel Extract, Potassium Sorbate, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Camellia Oleifera Leaf Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Tetrahexyldecyl Ascorbate, Lycium Chinense Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Erythritol, Punica Granatum (Pomegranate) Fruit Extract, Phenoxyethanol, Tocopherol, Citral, Glucose, Hydrolyzed Pea Protein, Sodium Chloride, Plankton Extract, Sodium Benzoate, Homarine HCL, Sodium Succinate, Arabidopsis Thaliana Extract, Micrococcus Lysate, Ergothioneine
- Prevention plus daily hydrating moisturizer 30 SPF/FPS
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INGREDIENTS AND APPEARANCE
IMAGE SKINCARE PREVENTION PLUS DAILY HYDRATING MOISTURIZER
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79458-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 171 g in 1000 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) HYDRATED SILICA (UNII: Y6O7T4G8P9) DIMETHICONE (UNII: 92RU3N3Y1O) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) TANGERINE PEEL (UNII: JU3D414057) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) CAPRYLIC ACID (UNII: OBL58JN025) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX) ANACYSTIS NIDULANS EXTRACT (UNII: UV4FTL6UAW) WATER (UNII: 059QF0KO0R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ORANGE PEEL (UNII: TI9T76XD44) TOCOPHEROL (UNII: R0ZB2556P8) LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) ERGOTHIONEINE (UNII: BDZ3DQM98W) GLYCERIN (UNII: PDC6A3C0OX) APPLE (UNII: B423VGH5S9) PEA PROTEIN (UNII: 7Q50F46595) CITRAL (UNII: T7EU0O9VPP) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) CASTOR OIL (UNII: D5340Y2I9G) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPANEDIOL (UNII: 5965N8W85T) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ALOE VERA LEAF (UNII: ZY81Z83H0X) LAURIC ACID (UNII: 1160N9NU9U) LIMONENE, (+)- (UNII: GFD7C86Q1W) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) LEMON PEEL (UNII: 72O054U628) SODIUM CHLORIDE (UNII: 451W47IQ8X) POMEGRANATE (UNII: 56687D1Z4D) SODIUM BENZOATE (UNII: OJ245FE5EU) HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N) SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) ISOHEXADECANE (UNII: 918X1OUF1E) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) BABASSU SEED (UNII: HL2549X1EY) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ERYTHRITOL (UNII: RA96B954X6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79458-001-00 170 g in 1 TUBE; Type 0: Not a Combination Product 03/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/17/2022 Labeler - Natural Technology, LLC (618561906)