10 ARMANI PRIMA CONTROL GLOW MOISTURIZER SBS SPF 35- octinoxate, titanium dioxide cream

10 Armani Prima Control Glow Moisturizer SBS SPF 35 by

Drug Labeling and Warnings

10 Armani Prima Control Glow Moisturizer SBS SPF 35 by is a Otc medication manufactured, distributed, or labeled by BPS 60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 dimethoicone crosspolymer, simmondsia chinensis (jojoba) seed oil, limonene, zinc gluconate, linalool, benzyl alcohol, copper gluconate, 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

Package Labeling:

INGREDIENTS AND APPEARANCE

10 ARMANI PRIMA CONTROL GLOW MOISTURIZER SBS SPF 35 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70581-019
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70581-019-00	1 in 1 BOX	01/01/2018
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	01/01/2018

Labeler - BPS 60 (272259304)