OBAGI 360- avobenzone, octinoxate, octisalate, oxybenzone kit

Obagi 360 by

Drug Labeling and Warnings

Obagi 360 by is a Otc medication manufactured, distributed, or labeled by OMP, Inc., G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

OBAGI 360 
avobenzone, octinoxate, octisalate, oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-580

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-580-88	1 in 1 CARTON; Type 0: Not a Combination Product	09/08/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	75 g
Part 2	1 TUBE	28 g
Part 3	1 TUBE	150 mL

Part 1 of 3

OBAGI  HYDRAFACTOR BROAD SPECTRUM SPF 30
sunscreen lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	10 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		75 g 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 final	part352

Part 2 of 3

OBAGI  RETINOL 0.5
night

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	RETINOL (UNII: G2SH0XKK91)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	SAFFLOWER OIL (UNII: 65UEH262IS)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	SORBITOL (UNII: 506T60A25R)
INGR	BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
INGR	GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 3 of 3

OBAGI  EXFOLIATING CLEANSER
other personal cleanliness products

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
INGR	SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	PAPAIN (UNII: A236A06Y32)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		150 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
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/08/2015

Labeler - OMP, Inc. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(62032-580) , LABEL(62032-580) , PACK(62032-580) , ANALYSIS(62032-580)