Label: BLI HOLDING MIAMI BEACH KIDS SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0074-4 - Packager: Prime Packaging, 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
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- reapply: •after 80 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours •hold container 4 to 6 inches from the skin to apply
- do not spray directly into face. Spray on hands then apply to face.
- do not apply in windy conditions •use in a well-ventilated area
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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 Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylane Copolymerm, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylphthalimide,Capylic/Capric Triglyceride, Crambe Maritima Extract, Disodium EDTA, Ethylhexylglycerin, Isopropylphthalimide, Phenoxyethanol, Potassium Cetyl Phosphate, Propylene Glycol, Pseudopterogorgia Elisabethae Plant Extract, Sorbitol, Styrene/ Acrylates Copolymer, Tocophenyl Acetate, Water
- Other Information
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- PRINCIPAL DISPLAY PANEL - 148 mL Can Label
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INGREDIENTS AND APPEARANCE
BLI HOLDING MIAMI BEACH KIDS SPF 50
avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0074 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.33 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 101.1 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50.55 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.8025 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20.22 mg in 1 mL Inactive Ingredients Ingredient Name Strength (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) CAPRYLIC/CAPRIC ACID (UNII: DI775RT244) CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B) SORBITOL (UNII: 506T60A25R) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0074-4 148 mL in 1 CAN; 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 Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0074) , analysis(13630-0074) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0074) , pack(13630-0074)
