ISLAND REMEDY ALL-DAY REVITALIZING MOISTURIZER WITH SPF 30- titanium dioxide, zinc oxide cream 
Aruba Aloe Balm NV

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Island Remedy All-day Revitalizing Moisturizer with SPF 30

Drug Facts

Active ingredients

Titanium Dioxide 5.78%

Zinc Oxide 3.74%

Purpose

Sunscreen

Uses

• Helps prevent sunburn • Higher SPF gives more sunburn protection.

Warnings

For external use only

Avoid contact with eyes, rinse with water to remove.

Stop use and consult a doctor

if rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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:

Inner Package Labeling:

Inner Label

Outer Package Labeling:

Outer Label

ISLAND REMEDY ALL-DAY REVITALIZING MOISTURIZER WITH SPF 30 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE57.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION37.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53675-160-001 in 1 BOX05/24/2016
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/24/2016
Labeler - Aruba Aloe Balm NV (855442273)

Revised: 11/2023
Document Id: 09862c49-6c44-2d7c-e063-6394a90ac5b3
Set id: 5d139e04-244f-4f38-bea4-20e029f50f85
Version: 3
Effective Time: 20231106
 
Aruba Aloe Balm NV