Obagi 360®

Obagi 360®
SPL v5
SPL
SPL Set ID 84f0f1dd-13f2-49f5-89b3-fab175ac2564
Route
TOPICAL
Published
Effective Date 2019-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (10 mg) Octinoxate (75 mg) Octisalate (50 mg) Oxybenzone
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Butyloctyl Salicylate Alkyl (c12-15) Benzoate Tara Spinosa Resin Caprylic Alcohol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Icodextrin Edetate Disodium Eperua Falcata Bark Ethylhexylglycerin Glycerin Hexylene Glycol Phenoxyethanol Polysorbate 20 Hyaluronate Sodium Sodium Hydroxide Sorbitan Monooleate .alpha.-tocopherol Acetate Ubidecarenone Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-01-02 Until 2019-12-31

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. If product gets into eyes, rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active ingredients Purpose
Avobenzone 1% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Oxybenzone 5% Sunscreen
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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: Ask a doctor
Other Information
  • store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • protect this product from excessive heat and direct sun
Inactive Ingredients

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

Questions Or Comments?

1.800.636.7546

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

Principal Display Panel 75 G Tube Carton

OBAGI®

MEDICAL

OBAGI360®

HydraFactor™

Moisturizing Cream

with Sunscreen

Broad Spectrum

SPF 30

Net wt. 2.5 oz. (75 g)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. If product gets into eyes, rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active ingredients Purpose
Avobenzone 1% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Oxybenzone 5% Sunscreen
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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: Ask a doctor
Other Information (Other information)
  • store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • protect this product from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1.800.636.7546

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

Principal Display Panel 75 G Tube Carton (PRINCIPAL DISPLAY PANEL - 75 g Tube Carton)

OBAGI®

MEDICAL

OBAGI360®

HydraFactor™

Moisturizing Cream

with Sunscreen

Broad Spectrum

SPF 30

Net wt. 2.5 oz. (75 g)


Advanced Ingredient Data


Raw Label Data

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