ALOE UP SPF 30 C/S SUNSCREEN WITH ALOE VERA- avobenzone, homosalate, octisalate, and octocrylene spray 
Prime Packaging Inc

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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Aloe Up SPF 30 C/S Sunscreen Aloe Vera

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120ºF

Stop use and ask a doctor if rash occurs

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

Flammable: Do not use near heat, flame or while smoking.

Directions

  • spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in a well-ventilated area
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

Aloe Barbadensis Extract, Alpha-Isomethyl Ionone, Benzyl Alcohol, Benzyl Benzoate, Cocos Nucifera (Coconut) Oil, Coumarin, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Limonene, Linalool, Mineral Oil (Paraffinum Liquidum), Polyester-8, SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

  • protect this product from excessive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration.

Questions or comments?

Call toll free 1-800-950-2563

SPF 30 C/S Sunscreen Aloe Vera

Principal Display Image

ALOE UP  SPF 30 C/S SUNSCREEN WITH ALOE VERA
avobenzone, homosalate, octisalate, and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0097
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE83 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.83 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE24.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZYL BENZOATE (UNII: N863NB338G)  
COCONUT OIL (UNII: Q9L0O73W7L)  
COUMARIN (UNII: A4VZ22K1WT)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
ALCOHOL (UNII: 3K9958V90M)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0097-4177 mL in 1 CAN; Type 0: Not a Combination Product12/28/201509/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/28/201509/06/2022
Labeler - Prime Packaging Inc (805987059)
Registrant - Prime Packaging Inc (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0097)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc805987059pack(13630-0097) , label(13630-0097)

Revised: 9/2022
 
Prime Packaging Inc