TARTEGUARD 30 SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion

TARTEGUARD 30 sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

TARTEGUARD 30 sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Tarte, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 3.36%	Sunscreen
Zinc Oxide 4.13%	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.
• 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, butyloctyl salicylate, coco-caprylate/caprate, C12-15 alkyl benzoate, caprylic/capric triglyceride, diheptyl succinate, polyglyceryl-6 distearate, propanediol, jojoba esters, glycerin, pyrus malus (apple) fruit extract, polysorbate 20, polyhydroxystearic acid, polymethylsilsesquioxane, potassium cetyl phosphate, phenoxyethanol, alumina, diethylhexyl syringylidenemalonate, xanthan gum, tocopherol, glycine soja (soybean) oil, capryloyl glycerin/sebacic acid copolymer, citric acid, triethoxycaprylylsilane, lonicera caprifolium (honeysuckle) flower extract, trisodium ethylenediamine disuccinate, chlorphenesin, fragrance, stearic acid, ethylhexylglycerin, passiflora edulis seed oil, lonicera japonica (honeysuckle) flower extract, algae extract, pseudoalteromonas exopolysaccharides, sodium hyaluronate, sodium salicylate, propylene glycol, sodium dehydroacetate.

SPL UNCLASSIFIED SECTION

Dist. by tarte™, Inc. NY 10018.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

RECOMMENDED
SKIN
CANCER
FOUNDATION
DAILY USE

tarte
high-performance naturals™

TARTEGUARD
30

sunscreen lotion
Broad Spectrum SPF 30

INGREDIENTS AND APPEARANCE

TARTEGUARD 30 SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	33.6 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	41.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
medium-chain triglycerides (UNII: C9H2L21V7U)
diheptyl succinate (UNII: 057N7SS26Y)
polyglyceryl-6 distearate (UNII: Z35I17EQOP)
propanediol (UNII: 5965N8W85T)
glycerin (UNII: PDC6A3C0OX)
apple (UNII: B423VGH5S9)
polysorbate 20 (UNII: 7T1F30V5YH)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
phenoxyethanol (UNII: HIE492ZZ3T)
aluminum oxide (UNII: LMI26O6933)
diethylhexyl syringylidenemalonate (UNII: 3V5U97P248)
xanthan gum (UNII: TTV12P4NEE)
tocopherol (UNII: R0ZB2556P8)
soybean oil (UNII: 241ATL177A)
anhydrous citric acid (UNII: XF417D3PSL)
triethoxycaprylylsilane (UNII: LDC331P08E)
lonicera caprifolium flower (UNII: 5N1WD9784U)
trisodium ethylenediamine disuccinate (UNII: YA22H34H9Q)
chlorphenesin (UNII: I670DAL4SZ)
stearic acid (UNII: 4ELV7Z65AP)
ethylhexylglycerin (UNII: 147D247K3P)
passiflora edulis seed oil (UNII: F3VOA31UHQ)
lonicera japonica flower (UNII: 4465L2WS4Y)
hyaluronate sodium (UNII: YSE9PPT4TH)
sodium salicylate (UNII: WIQ1H85SYP)
propylene glycol (UNII: 6DC9Q167V3)
sodium dehydroacetate (UNII: 8W46YN971G)
polyhydroxystearic acid (2300 MW) (UNII: YXH47AOU0F)
jojoba oil (UNII: 724GKU717M)
polymethylsilsesquioxane (11 microns) (UNII: Z570VEV8XK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-015-04	1 in 1 CARTON	04/01/2015
1		50 mL in 1 BOTTLE; 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	04/01/2015

Labeler - Tarte, Inc (027905186)