CARNIVAL ADVENTURES 30 SPORT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion 
Prime Enterprises 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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Carnival Adventures 30 Sport Sunscreen

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.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes.

Rinse with water to remove.

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

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply: • after 80 minutes of swimming or sweating

• immediately after towel drying • at least every 2 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 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-sleeved shirts, pants, hats, & sunglasses.
  • Children under 6 months: ask a doctor

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Crambe Maritima Leaf Extract, Disodium EDTA, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Porphyra Umbilicalis Extract, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Tocopheryl Acetate, Water

Other information

Protect product from excessive heat & direct sun.

Carnival Adventures 30 Sport Sunscreen Broad Spectrum SPF30

Principal Display Label

CARNIVAL ADVENTURES  30 SPORT SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0262
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE95.3 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.59 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.65 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26.21 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALLANTOIN (UNII: 344S277G0Z)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0262-3118 mL in 1 TUBE; Type 0: Not a Combination Product06/19/201806/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/19/201806/30/2022
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0262) , manufacture(58443-0262) , label(58443-0262) , analysis(58443-0262)

Revised: 10/2022
Document Id: eb894108-3048-f571-e053-2995a90afbdb
Set id: 7092c2a7-c554-496a-e053-2991aa0a4577
Version: 3
Effective Time: 20221021
 
Prime Enterprises Inc.