AMAZONIAN CLAY BB ILLUMINATING MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN- octinoxate, oxybenzone, and titanium dioxide cream 
Tarte, 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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Amazonian clay BB illuminating moisturizer Broad Spectrum SPF 15 Sunscreen

Drug Facts

Active ingredientsPurpose
Octinoxate 7.5%Sunscreen
Oxybenzone 3%Sunscreen
Titanium Dioxide 5%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

Stop use and ask doctor if rash occurs

Do not use on damaged or broken skin

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

Keep out of the 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
  • Optional: apply to all skin exposed to the sun
  • 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

Other information

  • Protect the product in this container from excessive heat and direct sunlight
  • You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.

Inactive ingredients

Water, cyclopentasiloxane, glycerin, PEG/PPG-18/18 dimethicone, dimethicone, sodium chloride, stearic acid, aluminum hydroxide, triethoxycaprylylsilane, calcium sodium phosphosilicate, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, saccharum officinarum (sugar cane) extract, pyrus malus (apple) fruit extract, citrus limon (lemon) fruit extract, citrus aurantium dulcis (orange) fruit extract, camellia sinensis leaf extract, chamomilla recutita (matricaria) flower extract, camellia oleifera leaf extract, panax ginseng root extract, ginkgo biloba leaf extract, anthemis nobilis flower extract, butylene glycol, phytantriol, kaolin, magnesium ascorbyl phosphate, retinyl palmitate, tocopherol, tetrahexyldecyl ascorbate, boron nitride, palmitic acid, dextrin palmitate, sodium hyaluronate, sodium dehydroacetate, methicone, phenoxyethanol, caprylyl glycol, hexylene glycol, titanium dioxide, iron oxides, mica.

Dist. by tarte™,
Inc. New York, NY 10018.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

tarte

high-performance naturals™

Amazonian clay BB
illuminating moisturizer

Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
AMAZONIAN CLAY BB ILLUMINATING MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN 
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
glycerin (UNII: PDC6A3C0OX)  
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)  
dimethicone (UNII: 92RU3N3Y1O)  
sodium chloride (UNII: 451W47IQ8X)  
stearic acid (UNII: 4ELV7Z65AP)  
aluminum hydroxide (UNII: 5QB0T2IUN0)  
triethoxycaprylylsilane (UNII: LDC331P08E)  
polyglyceryl-4 isostearate (UNII: 820DPX33S7)  
hexyl laurate (UNII: 4CG9F9W01Q)  
sugarcane (UNII: 81H2R5AOH3)  
apple (UNII: B423VGH5S9)  
lemon (UNII: 24RS0A988O)  
orange (UNII: 5EVU04N5QU)  
green tea leaf (UNII: W2ZU1RY8B0)  
chamomile (UNII: FGL3685T2X)  
camellia oleifera leaf (UNII: 5077EL0C60)  
asian ginseng (UNII: CUQ3A77YXI)  
ginkgo (UNII: 19FUJ2C58T)  
chamaemelum nobile flower (UNII: O2T154T6OG)  
butylene glycol (UNII: 3XUS85K0RA)  
phytantriol (UNII: 8LVI07A72W)  
kaolin (UNII: 24H4NWX5CO)  
magnesium ascorbyl phosphate (UNII: 0R822556M5)  
vitamin a palmitate (UNII: 1D1K0N0VVC)  
tocopherol (UNII: R0ZB2556P8)  
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
boron nitride (UNII: 2U4T60A6YD)  
palmitic acid (UNII: 2V16EO95H1)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
sodium dehydroacetate (UNII: 8W46YN971G)  
phenoxyethanol (UNII: HIE492ZZ3T)  
caprylyl glycol (UNII: 00YIU5438U)  
hexylene glycol (UNII: KEH0A3F75J)  
mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-017-011 in 1 CARTON02/01/201105/28/2016
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201105/28/2016
Labeler - Tarte, Inc (027905186)

Revised: 12/2018
 
Tarte, Inc