10 Armani Prima Color Control Glow Moisturizer Sbs Spf 35

10 Armani Prima Color Control Glow Moisturizer Sbs Spf 35
SPL v4
SPL
SPL Set ID 9dc66fbf-bc66-4c60-9675-05b193da91da
Route
TOPICAL
Published
Effective Date 2018-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (50 mg) Titanium Dioxide (19 mg)
Inactive Ingredients
Water Dimethicone Glycerin Alcohol Isododecane Peg-10 Dimethicone (600 Cst) Dipropylene Glycol Pentylene Glycol Disteardimonium Hectorite Betaine Talc Diisostearyl Malate .alpha.-tocopherol Acetate Macadamia Oil Phenoxyethanol Adenosine Magnesium Sulfate, Unspecified Form Magnesium Aspartate Ethylhexyl Hydroxystearate Ethyl Menthane Carboxamide Silicon Dioxide Jojoba Oil Limonene, (+)- Zinc Gluconate Linalool, (+/-)- Benzyl Alcohol Copper Gluconate Coriander Oil Moringa Oleifera Seed Passiflora Edulis Seed Oil Disodium Stearoyl Glutamate Methicone (20 Cst) Apricot Kernel Oil Aluminum Starch Octenylsuccinate Aluminum Oxide Aluminum Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-01

Description

Octinoxate 5% Titanium dioxide  1.9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 5% Titanium dioxide  1.9%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see  decreases the risk of skin cancer and early skin aging caused by the sun Directions), 
Warnings

For external use only

Do not use near fire, flame or heat. Flammable until dry. 

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
  • 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: Sun Protection Measures. 
  • 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
Do Not Use 

on damaged or broken skin

Other Information
  • protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients 

Octinoxate 5%

Titanium dioxide  1.9%

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

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.


Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see  decreases the risk of skin cancer and early skin aging caused by the sun Directions), 
Purpose

Sunscreen

Warnings

For external use only

Do not use near fire, flame or heat. Flammable until dry. 

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
  • 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: Sun Protection Measures. 
  • 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
Do Not Use  (Do not use )

on damaged or broken skin

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients  (Active ingredients )

Octinoxate 5%

Titanium dioxide  1.9%

Inactive Ingredients (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

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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


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Raw Label Data

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