BLI HOLDING MIAMI BEACH KIDS SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray

BLI Holding by

Drug Labeling and Warnings

BLI Holding by is a Otc medication manufactured, distributed, or labeled by Prime Packaging, Inc., Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Flammable: Do not use near heat, flame, or while smoking.

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120°F

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

• 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

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

protect this product from excessive heat and direct sun may stain fabrics.

Questions or comments?

Call 305.471.7989

PRINCIPAL DISPLAY PANEL - 148 mL Can Label

OFFICIAL SUNCARE

MB

MIAMIBEACH

MB LIFEGUARDS

KIDS

CONTINUOUS SPRAY

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

5 FL OZ (148mL)

INGREDIENTS AND APPEARANCE

BLI HOLDING  MIAMI BEACH KIDS SPF 50
avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray

Product 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)