Ocean Potion SPF 50 Baby Sunscreen Lotion

Ocean Potion by

Drug Labeling and Warnings

Ocean Potion by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OCEAN POTION BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
Prime Enterprises

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Ocean Potion SPF 50 Baby Sunscreen Lotion

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

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 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 am - 2 pm
• wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months: ask a doctor

Other Information

• for use on skin only. Avoid contact with fabric
• protect this product from excessive heat and direct sun

Inactive Ingredients

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

Questions or comments?

oceanpotion.com

OCEAN POTION  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0658
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.7 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	99 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CHAMOMILE (UNII: FGL3685T2X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CARBOMER 980 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCOA BUTTER (UNII: 512OYT1CRR)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0658-3	100 mL in 1 TUBE; Type 0: Not a Combination Product	05/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/03/2024

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	analysis(58443-0658) , label(58443-0658) , manufacture(58443-0658) , pack(58443-0658)

Revised: 5/2024

Document Id: 18aa47bd-6340-c61e-e063-6394a90af5ca

34390-5

Set id: 18aa4336-caa9-16e8-e063-6294a90a9fd1

Version: 1

Effective Time: 20240517