Carnival Adventures SPF 30 Sport Sunscreen (NDC: 52260-008-04)

Carnival Adventures 30 SPF Sport Sunscreen by

Drug Labeling and Warnings

Carnival Adventures 30 SPF Sport Sunscreen by is a Otc medication manufactured, distributed, or labeled by Worthy Promotional Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARNIVAL ADVENTURES 30 SPF SPORT SUNSCREEN- homosalate, octocrylene, avobenzone lotion 
Worthy Promotional Products, LLC

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.

----------

Carnival Adventures SPF 30 Sport Sunscreen (NDC: 52260-008-04)

Drug Facts
Active Ingredients

Homosalate 7%

Octocrylene 5%

Butyl Methoxydibenzoylmethane 1.8%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Do not use

on broken or damaged 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10am to 2pm
• wear long sleeved shirts, pants, hats and sunglasses

Children under 6 months: ask a doctor

Inactive Ingredients

water, glycerin, propylene glycol, glyceryl stearate, cetyl alcohol, PEG 100 Stearate, Oleth-4 phosphate, gluconolactone, sodium benzoate, polyethylene, fragrance, phenoxyethanol, carbomer, xanthan gum, sodium hydroxide, theobroma cacao seed butter, aloe barbadensis leaf juice, tocopheryl acetate, disodium EDTA

Other Information

Protect product from excessive heat and direct sun.

Product Label Image

Carnival Adventures SPF 30 Sport Sunscreen

Water Resistant (80 minutes)

Oil Free

4fl oz, 118mL

(NDC: 52260-008-04)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52260-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
OLETH-4 PHOSPHATE (UNII: 2TNJ2ZW7RW)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
XANTHAN GUM (UNII: TTV12P4NEE)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52260-008-04	118 g in 1 TUBE; Type 0: Not a Combination Product	04/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/19/2022	03/23/2023

Labeler - Worthy Promotional Products, LLC (078525055)

Revised: 3/2023

Document Id: f8349b89-6532-40ed-e053-6294a90aae5c

34390-5

Set id: dd05d6b9-4f57-da53-e053-2995a90a4ef1

Version: 2

Effective Time: 20230331