Active ingredients

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

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

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

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

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 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

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

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

Questions or Comments?

Call 305.471.7989

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

OFFICIAL SUNCARE

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)

PRINCIPAL DISPLAY PANEL - 7.4 mL Pouch

OFFICIAL SUNCARE

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)

BLI HOLDINGS MIAMI BEACH KIDS SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0147
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
(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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/01/2015

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0147) , pack(58443-0147) , manufacture(58443-0147) , analysis(58443-0147)