OBAGI 360- avobenzone, octinoxate, octisalate, oxybenzone 
OMP, 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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OBAGI 360™

Exfoliating Cleanser AM+PM

Works to help clear clogged pores that can cause dull, dry, uneven skin. Gentle microbeads aid exfoliation. Gently yet thoroughly cleans your skin to reveal a soft, smooth, radiant complexion.

Directions

Use twice daily, morning and evening. Wet hands and face, then massage cleanser onto skin with a gentle circular motion. Rinse with lukewarm water and gently pat dry.

Warnings

Avoid getting into eyes. For external use only. Keep out of reach of children.

Ingredients

water (aqua), polylactic acid, decyl glucoside, glycerin, sodium cocoyl isethionate, cocamidopropyl betaine, sodium lauroamphoacetate, sodium methyl cocoyl taurate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, phenoxyethanol, caprylyl glycol, sodium PCA, panthenol, sodium hydroxide, chlorphenesin, ethylhexylglycerin, hexylene glycol, disodium EDTA, sodium hyaluronate, papain, carbomer, 1,2-hexanediol, algin

Retinol 0.5 PM

Gradually releases retinol, refining the appearance of skin texture and tone for clearer-looking skin.

Directions

Once daily in the evening, apply a pearl-size amount to the face and gently smooth until absorbed.

Warnings

When using this product, you may experience mild redness, peeling, or skin irritation. These are normal, temporary indications the product is working. If irritation occurs, limit use to every other night, or as tolerated. When skin has adjusted, revert to daily use.

Do not use if you are pregnant, lactating, planning to become pregnant, taking prescription acne medication, have compromised skin such as flaring dermatitis, or are undergoing skin peeling treatments. Daily use of a broad spectrum sunscreen with an SPF of 30 or higher is highly recommended.

Avoid getting into eyes. If contact occurs, rinse thoroughly with water. For external use only. Keep out of reach of children.

Ingredients

water (aqua), caprylic/capric triglyceride, glyceryl stearate, cyclopentasiloxane, butylene glycol, stearic acid, butyrospermum parkii (shea) butter, polysorbate 60, stearyl alcohol, glycerin, retinol, polysorbate 20, dimethicone, carthamus tinctorius (safflower) seed oil, calendula officinalis flower extract, camellia oleifera leaf extract, camellia sinensis leaf extract, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, ascorbic acid, sodium hyaluronate, cyclohexasiloxane, sorbitol, BHT, bisabolol, allyl methacrylates crosspolymer, dimethicone/vinyl dimethicone crosspolymer, dipotassium glycyrrhizate, disodium EDTA, triethanolamine, carbomer, glyceryl acrylate/acrylic acid copolymer, caprylyl glycol, ethylhexylglycerin, hexylene, glycol, phenoxyethanol

HydraFactor Broad Spectrum SPF 30 AM

Drug Facts

Active ingredients

Avobenzone 1%
Octinoxate 7.5%

Octisalate 5%

Oxybenzone 5%

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

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: Ask a doctor
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

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, butyloctyl salicylate, C12-15 alkyl benzoate, caesalpinia spinosa gum, caprylyl glycol, carbomer, dextrin, disodium EDTA, eperua falcata bark extract, ethylhexylglycerin, glycerin, hexylene glycol, hydrolyzed caesalpinia spinosa gum, phenoxyethanol, pichia/resveratrol ferment extract, polysorbate 20, sodium hyaluronate, sodium hydroxide, sorbitan oleate, tocopheryl acetate, ubiquinone, water

Other information

store at controlled room temperature: 15°C–25°C (59°F–77°F)
protect this product from excessive heat and direct sun

Questions or comments?

1.800.636.7546
Monday–Friday 9 a.m.–4 p.m. Pacific Time

Principal Display Panel - Kit Carton

OBAGI 360

Exfoliating Cleanser

HydraFactor SPF 30

Retinol 0.5

OBAGI®

MEDICAL

Obagi 360 - Kit Carton
OBAGI 360 
avobenzone, octinoxate, octisalate, oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-580
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-580-881 in 1 CARTON; Type 0: Not a Combination Product09/08/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 75 g
Part 21 TUBE 28 g
Part 31 TUBE 150 mL
Part 1 of 3
OBAGI  HYDRAFACTOR BROAD SPECTRUM SPF 30
sunscreen lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EPERUA FALCATA BARK (UNII: L43J05M2KO)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
UBIDECARENONE (UNII: EJ27X76M46)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
175 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart352
Part 2 of 3
OBAGI  RETINOL 0.5
night
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRCAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGRCHAMOMILE (UNII: FGL3685T2X)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
INGRSORBITOL (UNII: 506T60A25R)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 3 of 3
OBAGI  EXFOLIATING CLEANSER
other personal cleanliness products
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRPAPAIN (UNII: A236A06Y32)  
INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/08/2015
Labeler - OMP, Inc. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-580) , LABEL(62032-580) , PACK(62032-580) , ANALYSIS(62032-580)

Revised: 9/2019
Document Id: 5fb93b87-bc82-40e8-992c-df8b72a72855
Set id: 4fa39b43-7a13-47de-88d6-6398a38c9de5
Version: 2
Effective Time: 20190917
 
OMP, Inc.