Label: CORRECT AND PROTECT SERUM BROAD SPECTRUM SPF 45- zinc oxide lotion
- NDC Code(s): 70381-120-01, 70381-120-02
- Packager: Murad, 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 November 29, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
Uses
- 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
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- 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.
-
Inactive ingredients
Isododecane, Water (Aqua), Dimethicone, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polymethylsilsesquioxane/Trimethylsiloxysilicate, C12-15 Alkyl Benzoate, Coco-Caprylate/Caprate, Ethylhexyl Palmitate, Polymethylsilsesquioxane, Glycerin, Tapioca Starch, Polyglyceryl-10 Dioleate, Polyhydroxystearic Acid, Fructooligosaccharides, Simmondsia Chinensis (Jojoba) Seed Oil, Lecithin, Butyrospermum Parkii (Shea) Butter, Beta Vulgaris (Beet) Root Extract, Hedychium Coronarium Root Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Niacinamide, Squalane, Urea, Yeast Amino Acids, Trehalose, Taurine, Inositol, Betaine, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Potassium Lactate, Ethylhexylglycerin, Lactic Acid, Leuconostoc/Radish Root Ferment Filtrate, Polysilicone-11, Disteardimonium Hectorite, Caprylyl/Capryl Glucoside, Decyl Glucoside, Propylene Carbonate, Caprylyl Glycol, Hexylene Glycol, Triethoxycaprylylsilane, Chlorphenesin, Phenoxyethanol, Iron Oxides (CI 77492)
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
-
INGREDIENTS AND APPEARANCE
CORRECT AND PROTECT SERUM BROAD SPECTRUM SPF 45
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70381-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17 g in 100 mL Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PROPANEDIOL (UNII: 5965N8W85T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ETHYLHEXYL PALMITATE (UNII: 2865993309) POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT) GLYCERIN (UNII: PDC6A3C0OX) STARCH, TAPIOCA (UNII: 24SC3U704I) POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6) JOJOBA OIL (UNII: 724GKU717M) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SHEA BUTTER (UNII: K49155WL9Y) BEET (UNII: N487KM8COK) HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9) TOMATO (UNII: Z4KHF2C175) NIACINAMIDE (UNII: 25X51I8RD4) SQUALANE (UNII: GW89575KF9) UREA (UNII: 8W8T17847W) AMINO ACIDS, SOURCE UNSPECIFIED (UNII: 0O72R8RF8A) TREHALOSE (UNII: B8WCK70T7I) TAURINE (UNII: 1EQV5MLY3D) INOSITOL (UNII: 4L6452S749) BETAINE (UNII: 3SCV180C9W) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) POTASSIUM LACTATE (UNII: 87V1KMK4QV) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LACTIC ACID, DL- (UNII: 3B8D35Y7S4) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) PROPYLENE CARBONATE (UNII: 8D08K3S51E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) Product Characteristics Color WHITE (Off-White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70381-120-02 1 in 1 CARTON 01/03/2022 1 NDC:70381-120-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/03/2022 Labeler - Murad, LLC (781254792) Establishment Name Address ID/FEI Business Operations Beauty Manufacturing Solutions Corp (BMSC) 783200723 MANUFACTURE(70381-120)
