Label: ISLAND REMEDY ALL-DAY REVITALIZING MOISTURIZER WITH SPF 30- titanium dioxide, zinc oxide cream
- NDC Code(s): 53675-160-00
- Packager: Aruba Aloe Balm NV
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
-
Directions
Apply a small amount on area of skin treatment, reapply frequently if necessary.
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:
Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Water (Aqua/Eau), Cetearyl Isononanoate, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-20, PEG-20 Glyceryl Stearate, Cetyl Palmitate, Ethylhexyl Methoxycrylene, C12-C15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Hydrogen Dimethicone, Butyloctyl Salicylate, Propylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate (Vitamin E Acetate), Bisabolol, Isostearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Arnica Montana Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Leaf Extract, Achillea Millefolium Extract, Calendula Offcinalis Flower Extract, Prunus Serotina (Wild Cherry) Bark Extract, Eugenia Caryophyllus (Clove) Flower Extract, Equisetum Hiemale Extract, Cymbopogon Schoenanthus Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C).
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ISLAND REMEDY ALL-DAY REVITALIZING MOISTURIZER WITH SPF 30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53675-160 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 57.8 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 37.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CETEARYL ISONONANOATE (UNII: P5O01U99NI) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8) CETYL PALMITATE (UNII: 5ZA2S6B08X) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LEVOMENOL (UNII: 24WE03BX2T) ISOSTEARIC ACID (UNII: X33R8U0062) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CHAMOMILE (UNII: FGL3685T2X) COMFREY LEAF (UNII: DG4F8T839X) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) PRUNUS SEROTINA BARK (UNII: 5D48E975HA) CLOVE (UNII: K48IKT5321) EQUISETUM HYEMALE (UNII: 59677RXH25) CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W) JOJOBA OIL (UNII: 724GKU717M) ASCORBIC ACID (UNII: PQ6CK8PD0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53675-160-00 1 in 1 BOX 05/24/2016 1 50 mL in 1 BOTTLE, PUMP; 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 05/24/2016 Labeler - Aruba Aloe Balm NV (855442273)
