ARUBA ALOE ISLAND REMEDY DAILY ULTRA ALOE- octinoxate, oxybenzone cream

ARUBA ALOE ISLAND REMEDY DAILY ULTRA ALOE by

Drug Labeling and Warnings

ARUBA ALOE ISLAND REMEDY DAILY ULTRA ALOE by is a Otc medication manufactured, distributed, or labeled by ARUBA ALOE BALM NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients                                             Purpose

Octinoxate 7.5%                                                Sunscreen

Oxybenzone 4.5%                                             Sunscreen

INDICATIONS & USAGE

Helps Prevent sunburn

Higher SPF gives more sunburn protection.

WARNINGS

Warnings

for external use only

Avoid contact with eyes, rince with water to remove.

STOP USE

Stop use and consult a doctor if rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out or reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

apply generously on skin to be exposed to sunlight before sun exposure

children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients: WATER, ARUBA ALOE VERA GEL, CETEARYL ISONONANOATE, CETEARYL ALCOHOL, GLYCERYL STEARATE, CETEARETH-20, PEG-20-GLYCERYL STEARATE, CETYL PALMITATE, EQUISETUM HIEMALE EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, CYMBOPOGON SCHOENANTHUS EXTRACT, PRUNUS SEROTINA (WILD CHERRY) BARK EXTRACT, EUGENIA CARYOPHYLLUS (CLOVE) FLOWER EXTRACT, DECYL OLEATE, DIMETHICONE, PROPYLENE GLYCOL, CARBOMER 940, TOCOPHERYL ACETATE (VITAMIN E ACETATE), SYMPHYTUM OFFICINALE LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, ARNICA MONTANA FLOWER EXTRACT, TRIETHANOLAMINE, JOJOBA OIL, DIAZOLIDINYL UREA, METHYLPARABEN, PROPYLPARABEN, DISODIUM EDTA, FRAGRANCE.

PRINCIPAL DISPLAY PANEL

ARUBA ALOE

ISLAND REMEDY

Island Remedy products are not tested on animals. MADE IN ARUBA BY ARUBA ALOE BALM INC PO BOX 360 ARUBA DUTCH CARIBBEAN

DISTRIBUTED IN THE USA BY ARUBA ALOE OF NORTH AMERICA L.L.C INDIANAPOLIS IN 46250

ARUBA ALOE

THE WORLDS FINEST ALOE

ISLAND REMEDY

SINCE 1890

DAILY ULTRA ALOE CREME SPF 15

A NATURAL ADVANTAGE
Deeply rooted in the shadow of the Watapana tree, an earthy island remedy thrives. Since 1890, it as grown into an entire line of skin care products known around the world for its moisturizing benefits. Experience the Aruba Aloe difference.

ARUBA ALOE ISLAND REMEDY

DAILY ULTRA ALOE CREME

SPF 15

4OZ 118 ML

DAILY ULTRA ALOE CREME

SPF 15

Essential for all-day protection, this powerful moisturizing creme is formulated with 10% Pure Aruba Aloe Vera, SPF 15 sunscreens. Comfrey and Arnica extracts to help neutralize the negative effects of the sun's rays while stimulating your skin's elasticity and cell-reviving capabilities. Helps prevent sunburn. Higher SPF gives more sunburn protection. for skin that sunburns easily.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARUBA ALOE ISLAND REMEDY DAILY ULTRA ALOE 
octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
EQUISETUM HYEMALE (UNII: 59677RXH25)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
CLOVE (UNII: K48IKT5321)
DECYL OLEATE (UNII: ZGR06DO97T)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
TROLAMINE (UNII: 9O3K93S3TK)
JOJOBA OIL (UNII: 724GKU717M)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-100-01	1 in 1 BOX	11/01/2010
1		118 mL in 1 JAR; 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	11/01/2010

Labeler - ARUBA ALOE BALM NV (855442273)