GIORGIO ARMANI LUMINESSENCE CC COLOR CONTROL BRIGHT MOISTURIZER BROAD SPECTRUM SPF 35 SUNSCREEN- octinoxate and titanium dioxide lotion 
-L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Octinoxate 5%

Titanium dioxide 1.85%

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

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

image of a carton

GIORGIO ARMANI LUMINESSENCE CC COLOR CONTROL BRIGHT MOISTURIZER BROAD SPECTRUM SPF 35 SUNSCREEN 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-585
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-585-011 in 1 CARTON11/01/201310/30/2023
130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-585-021 mL in 1 PACKET; Type 0: Not a Combination Product11/01/201310/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/201310/30/2023
Labeler - -L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(49967-585) , pack(49967-585)
Establishment
NameAddressID/FEIBusiness Operations
BPS60272259304pack(49967-585)

Revised: 1/2023
 
-L'Oreal USA Products Inc