TROPICAL OTTERS GLITTER SUNSCREEN SPF-50 - SUGAR SPARKLE- homosalate, octisalate, octocrylene, zinc oxide cream 
6174 INDUSTRIES, LLC

----------

TROPICAL OTTERS Glitter Sunscreen SPF-50 - Sugar Sparkle

Drug Facts

Active Ingredients

Homosalate 10.00%
Octisalate 5.00%
Octocrylene 5.00%
Zinc Oxide 4.00%

Purpose

Sunscreen

Uses:

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 use and ask a doctor if

  • rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, 

ask a health professional before use.

Directions

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Cosmetic Glitter (Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane 33), Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, FD&C Blue #1, FD&C Red #40

Questions?

1-980-202-1769

Package Labeling:

Label

TROPICAL OTTERS GLITTER SUNSCREEN SPF-50 - SUGAR SPARKLE 
homosalate, octisalate, octocrylene, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84164-460
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CARROT (UNII: L56Z1JK48B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CORN (UNII: 0N8672707O)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84164-460-00133 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/04/2024
Labeler - 6174 INDUSTRIES, LLC (110191799)

Revised: 3/2024
Document Id: 12fad27d-d6ee-6872-e063-6294a90a9586
Set id: cfd1e0c7-7e4c-41c1-8788-b73f83bf38c9
Version: 1
Effective Time: 20240306
 
6174 INDUSTRIES, LLC