ARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 50- octocrylene, octinoxate, oxybenzone, homosalate, octyl salicylate, avobenzone 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

Octocrylene 10.0%
Octinoxate 7.5%
Oxybenzone 6.0%
Homosalate 5.0%
Octyl Salicylate 5.0%
Avobenzone 3.0%

PURPOSE

Sunscreen

Uses

Helps prevent sunburn
Higher SPF gives more sunburn protection
Very Water Resistant (80 min)

Warnings

For external use only
Do not use on damaged or broken skin

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.

Directions

• Apply generously before sun exposure and as needed
• Children under 6 months of age; ask a doctor
• Use sunscreens with broad spectrum SPF values of 15 or higher regularly and as directed
• Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s rays are most intense
• Wear clothing to cover skin exposed to the sun; for example, long-sleeved shirts, pants, sunglasses, and broad-brimmed hats
  
• Reapply sunscreen at least every 2 hours, more often if you’re sweating or jumping in and out of the water

Inactive Ingredients

Water, Aloe Vera Gel (from Aruba), Dicaprylyl Carbonate, Pentaerythrityl Distearate, VP/Eicosene Copolymer, Dimethicone, Sodium Stearoyl Glutamate, Phenoxyethanol, Ethylparaben, Methylparaben, Propylparaben, Sodium Polyacrylate, Fragrance.

DESCRIPTION

VERY WATER RESISTANT SUNSCREEN BROAD SPECTRUM SPF 50+

Formulated with a unique blend of 100% Pure Aloe and Vitamin E, our Very Water Resistant Broad Spectrum SPF 50+ will leave your skin feeling soft and smooth while providing the sun protection your skin needs. Formulated to provide UVA/UVB Protection.

For total sun care, apply our ultra-hydrating After Sun Lotion following prolonged
exposure to the sun

Shop Browse Learn www.ArubaAloe.com

Made in Aruba by Aruba Aloe Balm Inc. P.O. 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.

This bottle contains 100% post-consumer
recycled plastic. Please recycle.
Aruba Aloe products are not tested
8.5 oz ( 251 mL) on animals.

Product Labeling

INGREDIENTS AND APPEARANCE

ARUBA ALOE VERY WATER RESISTANT SUNSCREEN   SPF 50
octocrylene, octinoxate, oxybenzone, homosalate, octyl salicylate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-158-08	251 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/26/2013

Labeler - Aruba Aloe Balm NV (855442273)