PROTECTION 50 BODY- avobenzone and octinoxate lotion

Protection 50 Body by

Drug Labeling and Warnings

Protection 50 Body by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Cosway, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 3.0%,
Octinoxate 7.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), helps decrease 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 30 minutes before sun exposure.
• Reapply:
  • - At least every two hours.
  • - Use a water resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help 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.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water/Aqua/Eau, Butylene Glycol, C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Cyclopentasiloxane, Aluminum Starch Octenylsuccinate, Cetearyl Phosphate, Polyglyceryl-2 Stearate, Dimethyl Capramide, VP/Eicosene Copolymer, Artemisia Pallens Flower Oil, Cananga Odorata Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Pelargonium Graveolens Flower Oil, Tagetes Minuta Flower Oil, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Caprylic/Capric Glycerides, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 156 mL Tube Carton

protection
50

sport

spf
50

broad
spectrum

UVA high protection

5.3 US FL OZ
156 mL e

dermalogica®

INGREDIENTS AND APPEARANCE

PROTECTION 50 BODY 
avobenzone and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Dimethyl Capramide (UNII: O29Y6X2JEZ)
Davana Oil (UNII: CL439Y041G)
Cananga Oil (UNII: 8YOY78GNNX)
Orange Oil (UNII: AKN3KSD11B)
Grapefruit Oil (UNII: YR377U58W9)
Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)
Tagetes Minuta Flower Oil (UNII: 1T0ZMU8M8B)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Docosanol (UNII: 9G1OE216XY)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Xanthan Gum (UNII: TTV12P4NEE)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Hydroxide (UNII: 55X04QC32I)
Ethylhexylglycerin (UNII: 147D247K3P)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-230-02	1 in 1 CARTON
1		156 mL in 1 TUBE
2	NDC: 68479-230-01	22 mL in 1 TUBE
3	NDC: 68479-230-00	2 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/08/2013

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		620899877	MANUFACTURE(68479-230)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-230)