GIORGIO ARMANI ARMANIPRIMA COLOR CONTROL GLOW MOISTURIZER BROAD SPECTRUM SPF 35 SUNSCREEN- octinoxate and titanium dioxide lotion

Giorgio Armani ArmaniPrima Color Control Glow Moisturizer Broad Spectrum SPF 35 Sunscreen by

Drug Labeling and Warnings

Giorgio Armani ArmaniPrima Color Control Glow Moisturizer Broad Spectrum SPF 35 Sunscreen by is a Otc medication manufactured, distributed, or labeled by -L'Oreal USA Products Inc, SICOS ET CIE, BPS60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 5%

Titanium dioxide 1.9%

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

Flammable until dry.

Do not use near fire, flame or heat.

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

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 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 decrease this risk, regularly 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 a.m. – 2 p.m.

● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, dimethicone, glycerin, alcohol denat., isododecane, PEG-10 dimethicone, dipropylene glycol, pentylene glycol, disteardimonium hectorite, betaine, talc, diisostearyl malate, fragrance, tocopheryl acetate, macadamia ternifolia seed oil, phenoxyethanol, adenosine, magnesium sulfate, magnesium aspartate, ethylhexyl hydroxystearate, ethyl menthane carboxamide, silica, dimethiconol, dimethicone/vinyl dimethicone crosspolymer, simmondsia chinensis (jojoba) seed oil, limonene, zinc gluconate, linalool, benzyl alcohol, copper glyconate, coriandrum sativum (coriander) fruit oil, moringa pterygosperma seed extract, passiflora edulis seed oil, disodium stearoyl glutamate, methicone, prunus armeniaca (apricot) kernel oil, aluminum starch octenylsuccinate, alumina, aluminum hydroxide; may contain: red 28 lake, red 7, iron oxides, bismuth oxychloride, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GIORGIO ARMANI ARMANIPRIMA COLOR CONTROL GLOW MOISTURIZER BROAD SPECTRUM SPF 35 SUNSCREEN 
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	19 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BETAINE (UNII: 3SCV180C9W)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MACADAMIA OIL (UNII: 515610SU8C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ADENOSINE (UNII: K72T3FS567)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
JOJOBA OIL (UNII: 724GKU717M)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
COPPER GLUCONATE (UNII: RV823G6G67)
CORIANDER OIL (UNII: 7626GC95E5)
MORINGA OLEIFERA SEED (UNII: TIX5482832)
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
METHICONE (20 CST) (UNII: 6777U11MKT)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-037-01	1 in 1 CARTON	01/15/2018
1		30 mL in 1 TUBE; 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	01/15/2018

Labeler - -L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-037) , pack(49967-037)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Biocosm SARL		288479491	pack(49967-037)