ARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15- octinoxate, oxybenzone lotion

Aruba Aloe Very Water Resistant Sunscreen by

Drug Labeling and Warnings

Aruba Aloe Very Water Resistant Sunscreen by is a Otc medication manufactured, distributed, or labeled by Aruba Aloe Balm, NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5%
Oxybenzone 4.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• Retains SPF after 80minutes of activity in the water
  

Warnings

For external use only/

When using this product

keep out of eyes, rinse with water to remove

Stop using and ask a doctor

if rash or irritation develops and lasts

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Directions

Apply generously before sun exposure and as needed

Children under 6 months of age; ask a doctor

Inactive Ingredients

Water, Aruba Aloe Vera gel, VP/Eicosene Copolymer, stearic acid, cetyl phosphate, cetearyl alcohol, coconut oil, jojoba oil, tocopheryl acetate (Vitamin E Acetate), myristyl myristate, dimethicone, carbomer 934, phenoxyethanol, ethlparabven, methylparaben, propylparaben, triethanolamine, fragrance

SPL UNCLASSIFIED SECTION

www.arubaaloe.com

Made in Aruba by Aruba Aloe Balm, Inc

PO Box 360, Aruba Dutch Caribbean. Distributed in the USA by Aruba Aloe of North America, LLC, Indianapolis, IN 46244. Customer inquiry Hotline: 1-800-95 ARUBA

Description

This bottle contains 100% post consumer recycled plastic. Please recycle. Aruba Aloe products are not tested on animals.

PRINCIPAL DISPLAY PANEL

ARUBA ALOE

since 1890

Very Water Resistant

Sunscreen SPF 15

Made in Aruba with the Worlds Finest Aloe (tm)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARUBA ALOE VERY WATER RESISTANT SUNSCREEN   SPF 15
octinoxate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-155
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)
ACETATE ION (UNII: 569DQM74SC)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER 934 (UNII: Z135WT9208)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-155-02	65 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2011
2	NDC: 53675-155-06	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/08/2011

Labeler - Aruba Aloe Balm, NV (855442273)