BO SPF15- avobenzone, octinoxate lotion

BO SPF15 by

Drug Labeling and Warnings

BO SPF15 by is a Otc medication manufactured, distributed, or labeled by Mana Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.00%
Octinoxate 7.50%

Use

• Helps prevens sunburn
• If used as direced with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin again 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 docor if rash occurs
• Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Use water resistant sunscreen if swimming or sweathing
• Reapply at least every 2 hours
• Children under 6 months: ask a doctor
• Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun especially from 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Water (Aqua), Butylene Glycol, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Hydrogenated Vegetable Oil, Glyceryl Stearate, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Oligopepetide-68, Butyrospermum Parkii (Shea) Buter, Theobroma Cacao (Cocoa) Seed Buter, Diethylhexyl Syringylidenemalonate, Ethylhexylglycerin, Coco-Glucoside, Ammonium Acryloyldimethyltaurate/VP Copolyner, Crambe Abyssinica Seed Oil, Olea Europaea (Olive) Fruit Oil, Hydrogenated Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Panthenol, Citrus Unshiu Peel Extract, Nymphaea Alba Flower Extract, Glycerin, Undecylenoyl Phenylalanine, Sodium Palmitoyl Proline, Ceteth-20, PEG-75 Stearate, Sodium Oleate, Steareth-20, Carbomer, Sodium Hydroxide, Disodium EDTA, o-Cymen-5-ol, Phenoxyethanol, Fragrance (Parfum)

Other Information

Protect this product form excessive heat and direct sun

Principal Display Panel

INGREDIENTS AND APPEARANCE

BO SPF15 
avobenzone, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
CETETH-20 (UNII: I835H2IHHX)
PEG-75 STEARATE (UNII: OT38R0N74H)
SODIUM OLEATE (UNII: 399SL044HN)
STEARETH-20 (UNII: L0Q8IK9E08)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-100-01	75 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/27/2013

Labeler - Mana Products (078870292)

Registrant - Mana Products (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
Mana Products		078870292	manufacture(59735-100)