Tropic Sun SPF 50 Sunscreen Lotion Sport

Tropic Sun by

Drug Labeling and Warnings

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

Drug Details [pdf]

TROPIC SUN SPF 50- 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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Tropic Sun SPF 50 Sunscreen Lotion Sport

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

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.

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.

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 of 15 or higher and other sun protection measure 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

Other information

Protect from excessive heat and direct sun.

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Questions or comments?

305-625-4929

Tropic Sun SPF 50 Sunscreen Lotion Sport

TROPIC SUN  SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0399
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.76 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	99.2 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49.6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYPROMELLOSES (UNII: 3NXW29V3WO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCOA BUTTER (UNII: 512OYT1CRR)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Product Characteristics
Color	white (White to Off White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0399-4	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2021	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/03/2021	12/31/2021

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(58443-0399) , label(58443-0399) , analysis(58443-0399) , pack(58443-0399)

Revised: 5/2022

Document Id: ded13ebe-460a-31b0-e053-2a95a90a04ee

34390-5

Set id: ba888df7-d258-0a6a-e053-2a95a90a9062

Version: 2

Effective Time: 20220512