Label: CONCEPT II SOLSCENTS BROAD SPECTRUM SPF 50 RASPBERRY DREAMS- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0217-4 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 17, 2020
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- Official Label (Printer Friendly)
- 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 of 15 or higher and other sun protection measures 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.
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INACTIVE INGREDIENT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)
- Other Information
- Questions or comments?
- Concept II SolScents Broad Spectrum SPF 50 Raspberry Dreams
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INGREDIENTS AND APPEARANCE
CONCEPT II SOLSCENTS BROAD SPECTRUM SPF 50 RASPBERRY DREAMS
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0217 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 125 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) HYPROMELLOSES (UNII: 3NXW29V3WO) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) CARBOMER 940 (UNII: 4Q93RCW27E) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALLANTOIN (UNII: 344S277G0Z) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) COCOA BUTTER (UNII: 512OYT1CRR) EDETATE DISODIUM (UNII: 7FLD91C86K) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0217-4 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/23/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/23/2013 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0217) , manufacture(58443-0217) , label(58443-0217)
