Label: ARAMORE MULTI-DEFENSE SUNSCREEN - AM BROAD SPECTRUM SPF 30- zinc oxide lotion
- NDC Code(s): 83127-101-11, 83127-101-12, 83127-101-13, 83127-101-14
- Packager: New Frontier Bio, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 30, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
- CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
- USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
- REAPPLY 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 10 A.M. - 2 P.M.
- WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
- OTHER INFORMATION
-
INACTIVE INGREDIENTS
Water (Aqua), Caprylic/Capric Triglyceride, Dimethicone, Glycerin, Cetearyl Alcohol, Polymethylsilsesquioxane, Propanediol, Coco-Glucoside, Sodium Hyaluronate, Ferulic Acid, Linoleic Acid, Linolenic Acid, Niacinamide, Bisabolol, Rutin, Tocopherol, Hydroxyacetophenone, Butyrospermum Parkii (Shea) Butter, Citrus Paradisi (Grapefruit) Peel Extract, Zingiber Officinale (Ginger) Root Extract, Ipomoea Batatas Root Extract, Oryza Sativa Hull Extract, Camellia Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Saccharomyces Lysate, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Polyglyceryl-3 Ricinoleate, Polyhydroxystearic Acid, Isostearic Acid, Glyceryl Caprylate, Cetearyl Glucoside, Decyl Glucoside, Glyceryl Oleate Citrate, Lecithin, Pullulan, Xanthan Gum, Sclerotium Gum, Polysilicone-11, Sodium Hydroxide, 1,2-Hexanediol, Pentylene Glycol, Caprylyl Glycol, Sodium Benzoate, Caprylhydroxamic Acid, Ethylhexyl Palmitate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARAMORE MULTI-DEFENSE SUNSCREEN - AM BROAD SPECTRUM SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83127-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) ISOSTEARIC ACID (UNII: X33R8U0062) PULLULAN (UNII: 8ZQ0AYU1TT) XANTHAN GUM (UNII: TTV12P4NEE) BETASIZOFIRAN (UNII: 2X51AD1X3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM BENZOATE (UNII: OJ245FE5EU) PROPANEDIOL (UNII: 5965N8W85T) NIACINAMIDE (UNII: 25X51I8RD4) RUTIN (UNII: 5G06TVY3R7) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SHEA BUTTER (UNII: K49155WL9Y) GRAPEFRUIT PEEL (UNII: 3582N05Q44) RICE GERM (UNII: 7N2B70SFEZ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PENTYLENE GLYCOL (UNII: 50C1307PZG) LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) COCO GLUCOSIDE (UNII: ICS790225B) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LINOLENIC ACID (UNII: 0RBV727H71) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) ETHYLHEXYL PALMITATE (UNII: 2865993309) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) LINOLEIC ACID (UNII: 9KJL21T0QJ) TOCOPHEROL (UNII: R0ZB2556P8) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) FERULIC ACID (UNII: AVM951ZWST) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) GINGER (UNII: C5529G5JPQ) SWEET POTATO (UNII: M9WGG9Z9GK) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83127-101-12 1 in 1 BOX 12/09/2022 1 NDC:83127-101-11 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:83127-101-14 1 in 1 BOX 12/09/2022 2 NDC:83127-101-13 15 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 12/09/2022 Labeler - New Frontier Bio, Inc (118602172)
