Label: BLI HOLDINGS MIAMI BEACH KIDS SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0147-2, 58443-0147-4 - Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
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Sun Protection Measures. Spending time in the sun increases our risk of skin cancer and earl 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 Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Beta-Carotene, Butylphthalimide, C12-15 Alkyl Benzoate, Caprylic/ Capric Triglyceride, Carbomer, Crambe Maritima Extract, Disodium EDTA, Ethylhexyglycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Propylene Glycol, Prunus Ameniaca (Apricot) Kernel Oil, Pseudopterogorgia Elisabethae Plant Extract, Sodium Hydroxide, Solanum Lycopersicum (Tomato) Fruit/Leaf/Steam Extract, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water (Aqua), Zea Mays (Corn) Oil
- Other information
- Questions or Comments?
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PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
OFFICIAL SUNCARE
MB
MIAMIBEACH
MB LIFEGUARDS
KIDS
Sunscreen Lotion
Broad Spectrum SPF 50
UVA/UVB Protection
Water Resistant (80 Minutes)
Dye-Free, Fragrance-Free
Hypoallergenic for Sensitive Skin
Made with Blend of Natural
Marine Extracts
6 FL OZ (177mL)
OFFICIAL SUNCARE
MB
MIAMIBEACH
MB LIFEGUARDS
KIDS
Sunscreen Lotion
Broad Spectrum
SPF 50
UVA/UVB Protection
Water Resistant (80 Minutes)
Dye-Free, Fragrance-Free
Hypoallergenic for Sensitive Skin
Made with Blend of Natural
Marine Extracts
0.25 FL OZ (7.4mL)
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INGREDIENTS AND APPEARANCE
BLI HOLDINGS MIAMI BEACH KIDS SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0147 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.225 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 29.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLIC/CAPRIC ACID (UNII: DI775RT244) CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HYPROMELLOSES (UNII: 3NXW29V3WO) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) APRICOT KERNEL OIL (UNII: 54JB35T06A) WATER (UNII: 059QF0KO0R) SOLANUM LYCOPERSICUM (UNII: 0243Q4990L) SODIUM HYDROXIDE (UNII: 55X04QC32I) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) COCOA BUTTER (UNII: 512OYT1CRR) CORN OIL (UNII: 8470G57WFM) .BETA.-CAROTENE (UNII: 01YAE03M7J) Product Characteristics Color orange Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0147-4 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2015 2 NDC:58443-0147-2 7.4 mL in 1 POUCH; Type 0: Not a Combination Product 03/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2015 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0147) , pack(58443-0147) , manufacture(58443-0147) , analysis(58443-0147)