Very Water Resistant Sunscreen SPF 50+

Very Water Resistant Sunscreen SPF 50+

Drug Labeling and Warnings

Drug Details

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ARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 50- octocrylene, octinoxate, oxybenzone, homosalate, octyl salicylate, avobenzone lotion 
Aruba Aloe Balm NV

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Very Water Resistant Sunscreen SPF 50+

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.

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

Aruba Aloe

Since 1890

Very Water Resistant Sunscreen

SPF 50+

Broad Spectrum UVA/UVB Protection

Made in Aruba

Worlds Finest Aloe

8.5ox (251mL)




Sunscreen

Sunscreen

ARUBA ALOE VERY WATER RESISTANT SUNSCREEN  SPF 50
octocrylene, octinoxate, oxybenzone, homosalate, octyl salicylate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53675-158
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53675-158-08251 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/26/2013
Labeler - Aruba Aloe Balm NV (855442273)

Revised: 2/2013
 
Aruba Aloe Balm NV


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