Label: OCEAN POTION BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 82956-0004-4
- Packager: Prime Matter Labs West
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 3, 2024
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- Active Ingredients
- Purpose
- Uses
- Warnings
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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
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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, Fragrance, 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
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INGREDIENTS AND APPEARANCE
OCEAN POTION BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82956-0004 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:82956-0004-4 201 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 Matter Labs West (118568102) Registrant - Prime Matter Labs West (118568102) Establishment Name Address ID/FEI Business Operations Prime Matter Labs West 118568102 label(82956-0004) , pack(82956-0004) , manufacture(82956-0004) Establishment Name Address ID/FEI Business Operations Prime Enterprises 101946028 analysis(82956-0004)
