ARAMORE MULTI-DEFENSE SUNSCREEN - AM BROAD SPECTRUM SPF 30- zinc oxide lotion

ARAMORE MULTI-DEFENSE SUNSCREEN - AM by

Drug Labeling and Warnings

ARAMORE MULTI-DEFENSE SUNSCREEN - AM by is a Otc medication manufactured, distributed, or labeled by New Frontier Bio, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 20%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

WARNINGS

• 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

• KEEP OUT OF REACH OF CHILDREN.
• IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

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

INGREDIENTS AND APPEARANCE

ARAMORE MULTI-DEFENSE SUNSCREEN - AM  BROAD SPECTRUM SPF 30
zinc oxide lotion

Product 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)