Label: MIAMI BEACH SPF 50 KIDS C/S SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0104-4 - 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 and 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
- 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
Water (Aqua), Styrene/Acrylates Copolymer, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane, Sorbitol, Octocrylene, Dimethicone, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Potassium Cetyl Phosphate, Fragrance (Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Disodium EDTA, Tocopheryl Acetate, Butylphenyl Methylpropional, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Hexyl Cinnamal, Linalool, Geraniol, Alpha-Isomethyl Ionone, Caprylic/Capric Triglyceride, Benzyl Salicylate, Propylene Glycol, Hydroxycitronellal, Limonene, Crambe Maritima Extract, Pseudopterogorgia Elisabethae Plant Extract
- Other Information
- Question or comments?
- Miami Beach SPF 50 C/S Sunscreen
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INGREDIENTS AND APPEARANCE
MIAMI BEACH SPF 50 KIDS C/S SUNSCREEN
avobenzone, homosalate, octisalate, and octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.66 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 102.2 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 51.1 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 28.11 mg in 1 mL Inactive Ingredients Ingredient Name Strength STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) DIMETHICONE (UNII: 92RU3N3Y1O) CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ALOE VERA LEAF (UNII: ZY81Z83H0X) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM (UNII: 7FLD91C86K) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0104-4 177 mL in 1 CAN; Type 0: Not a Combination Product 02/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/29/2016 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0104) , analysis(13630-0104) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0104) , label(13630-0104)