MOROCCANOIL SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Moroccanoil SPF 50 by

Drug Labeling and Warnings

Moroccanoil SPF 50 by is a Otc medication manufactured, distributed, or labeled by Moroccanoil, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Sunscreen

ACTIVE INGREDIENTS

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 2.7%

Oxybenzone 6%

USES

Helps prevent sunburn.

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

DIRECTIONS

Shake bottle before use.

Apply liberally over clean skin 15 minutes before sun exposure.

Reapply:

-- After 40 minutes of swimming or sweating.

-- Immediately after towel-drying.

-- At least every 2 hours.

Protect this product from excessive heat and direct sun.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To help prevent 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 am – 2 pm.

-- Wear long-sleeved shirts, hats and sunglasses.

Children under 6 months: Ask a doctor.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

WARNINGS

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. In case of contact, 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 a way.

INACTIVE INGREDIENTS

AQUA (WATER), C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, GLYCERIN, CYCLOPENTASILOXANE, POLYESTER-7, HYDROGENATED DIMER DILINOLEYL/DIMETHYLCARBONATE COPOLYMER, NEOPENTYL GLYCOL DIHEPTANOATE, DIMETHICONE, TRIMETHYLSILOXYSILICATE, PARFUM (FRAGRANCE), ARGANIA SPINOSA KERNEL OIL, BENZOTRIAZOLYL DODECYL P-CRESOL, COCOS NUCIFERA (COCONUT) OIL, TOCOPHERYL ACETATE, SOYBEAN GLYCERIDES, GARDENIA TAHITENSIS FLOWER EXTRACT, TOCOPHEROL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, LAURYL GLUCOSIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER, POLYBUTENE, XANTHAN GUM, CITRIC ACID, POTASSIUM SORBATE, METHYLISOTHIAZOLINONE.

QUESTIONS OR COMMENTS?

Call toll-free 1-888-700-1817

PACKAGING

Product Bottle

Product Box

INGREDIENTS AND APPEARANCE

MOROCCANOIL SPF 50 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69942-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
COCONUT OIL (UNII: Q9L0O73W7L)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
TOCOPHEROL (UNII: R0ZB2556P8)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69942-050-01	1 in 1 BOX	06/01/2015
1		150 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2015

Labeler - Moroccanoil, Inc. (964352202)

Registrant - Moroccanoil, Inc. (964352202)