MOROCCANOIL SUN OIL SPF 15- avobenzone, octinoxate, octisalate, octocrylene spray

Moroccanoil Sun Oil SPF 15 by

Drug Labeling and Warnings

Moroccanoil Sun Oil SPF 15 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%
Octinoxate 6.993%
Octisalate 3%
Octocrylene 7%

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 80 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 a ging. 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 dama ged 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

ARGANIA SPINOSA (ARGAN) KERNEL OIL, BHT, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOGLYCERIDES, COCOS NUCIFERA (COCONUT) OIL, CYCLOPENTASILOXANE, GARDENIA TAHITENSIS FLOWER EXTRACT, ISOPROPYL MYRISTATE, FRAGRANCE, POLYBUTENE, TOCOPHEROL, TOCOPHERYL ACETATE

QUESTIONS OR COMMENTS?

Call toll-free 1-888-700-1817

PACKAGING

Product Bottle Label

Product Box Label

INGREDIENTS AND APPEARANCE

MOROCCANOIL SUN OIL SPF 15 
avobenzone, octinoxate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69942-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.993 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69942-015-01	1 in 1 BOX	06/01/2015
1		150 mL in 1 BOTTLE, SPRAY; 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)