CARNIVAL ADVENTURES 30 SPORT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

Carnival Adventures by

Drug Labeling and Warnings

Carnival Adventures by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CARNIVAL ADVENTURES  30 SPORT SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0262
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	95.3 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.59 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.65 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26.21 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0262-3	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/19/2018

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0262) , manufacture(58443-0262) , label(58443-0262) , analysis(58443-0262)