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

Island Remedy All-day Revitalizing Moisturizer with SPF 30 by

Drug Labeling and Warnings

Island Remedy All-day Revitalizing Moisturizer with SPF 30 by is a Otc medication manufactured, distributed, or labeled by Aruba Aloe Balm NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

Outer Package Labeling:

INGREDIENTS AND APPEARANCE

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

Product 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 not final	part352	05/24/2016

Labeler - Aruba Aloe Balm NV (855442273)