RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIR- titanium dioxide and zinc oxide liquid RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT- titanium dioxide and zinc oxide liquid RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT-MEDIUM- titanium dioxide and zinc oxide liquid RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM- titanium dioxide and zinc oxide liquid RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN TAN- titanium dioxide and zinc oxide liquid RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN DEEP- titanium dioxide and zinc oxide liquid

Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen 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 6%	Sunscreen
Zinc Oxide 4%	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

• Shake before use.
• 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

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, NJ 08536-0222.

Inactive ingredients

Water, glycerin, isododecane, cyclopentasiloxane, phenyl trimethicone, nylon-12, dipropylene glycol, caprylic/ capric triglyceride, cyclohexasiloxane, SD alcohol 40-B, aluminum starch octenylsuccinate, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, magnesium sulfate, alumina, PEG-9 polydimethylsiloxyethyl dimethicone, silica, talc, iron oxides, sorbitan isostearate, stearalkonium hectorite, polyglyceryl-4 isostearate, hexyl laurate, aluminum hydroxide, stearic acid, caprylyl glycol, propylene carbonate, dimethicone, hydrogen dimethicone, phenoxyethanol, triethoxycaprylylsilane, tocopheryl acetate, 1,2-hexanediol, cocos nucifera (coconut) oil, algae extract, gardenia tahitensis flower, tocopherol.

SPL UNCLASSIFIED SECTION

Dist. by tarte™, Inc. NY 10018.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - fair

tarte
high-performance naturals™

rainforest of the sea
water foundation

Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - light

tarte
high-performance naturals™

rainforest of the sea
water foundation

Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - light-medium

tarte
high-performance naturals™

rainforest of the sea
water foundation

Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - medium

tarte
high-performance naturals™

rainforest of the sea
water foundation

Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - tan

tarte
high-performance naturals™

rainforest of the sea
water foundation

Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - deep

tarte
high-performance naturals™

rainforest of the sea
water foundation

Broad Spectrum
SPF 15 Sunscreen

INGREDIENTS AND APPEARANCE

RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   FAIR
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
isododecane (UNII: A8289P68Y2)
cyclomethicone 5 (UNII: 0THT5PCI0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
nylon-12 (UNII: 446U8J075B)
dipropylene glycol (UNII: E107L85C40)
medium-chain triglycerides (UNII: C9H2L21V7U)
cyclomethicone 6 (UNII: XHK3U310BA)
aluminum starch octenylsuccinate (UNII: I9PJ0O6294)
butylene glycol (UNII: 3XUS85K0RA)
magnesium sulfate anhydrous (UNII: ML30MJ2U7I)
aluminum oxide (UNII: LMI26O6933)
PEG-9 polydimethylsiloxyethyl dimethicone (UNII: TYP81E471F)
silicon dioxide (UNII: ETJ7Z6XBU4)
talc (UNII: 7SEV7J4R1U)
ferric oxide red (UNII: 1K09F3G675)
sorbitan isostearate (UNII: 01S2G2C1E4)
stearalkonium hectorite (UNII: OLX698AH5P)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
caprylyl glycol (UNII: 00YIU5438U)
propylene carbonate (UNII: 8D08K3S51E)
dimethicone (UNII: 92RU3N3Y1O)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
1,2-hexanediol (UNII: TR046Y3K1G)
coconut oil (UNII: Q9L0O73W7L)
gardenia taitensis flower (UNII: T0OCU8201Y)
tocopherol (UNII: R0ZB2556P8)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-081-01	1 in 1 CARTON
1		30 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	09/01/2015

RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
isododecane (UNII: A8289P68Y2)
cyclomethicone 5 (UNII: 0THT5PCI0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
nylon-12 (UNII: 446U8J075B)
dipropylene glycol (UNII: E107L85C40)
medium-chain triglycerides (UNII: C9H2L21V7U)
cyclomethicone 6 (UNII: XHK3U310BA)
aluminum starch octenylsuccinate (UNII: I9PJ0O6294)
butylene glycol (UNII: 3XUS85K0RA)
magnesium sulfate anhydrous (UNII: ML30MJ2U7I)
aluminum oxide (UNII: LMI26O6933)
PEG-9 polydimethylsiloxyethyl dimethicone (UNII: TYP81E471F)
silicon dioxide (UNII: ETJ7Z6XBU4)
talc (UNII: 7SEV7J4R1U)
ferric oxide red (UNII: 1K09F3G675)
sorbitan isostearate (UNII: 01S2G2C1E4)
stearalkonium hectorite (UNII: OLX698AH5P)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
caprylyl glycol (UNII: 00YIU5438U)
propylene carbonate (UNII: 8D08K3S51E)
dimethicone (UNII: 92RU3N3Y1O)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
1,2-hexanediol (UNII: TR046Y3K1G)
coconut oil (UNII: Q9L0O73W7L)
gardenia taitensis flower (UNII: T0OCU8201Y)
tocopherol (UNII: R0ZB2556P8)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-082-01	1 in 1 CARTON
1		30 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	09/01/2015

RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT-MEDIUM
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
isododecane (UNII: A8289P68Y2)
cyclomethicone 5 (UNII: 0THT5PCI0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
nylon-12 (UNII: 446U8J075B)
dipropylene glycol (UNII: E107L85C40)
medium-chain triglycerides (UNII: C9H2L21V7U)
cyclomethicone 6 (UNII: XHK3U310BA)
aluminum starch octenylsuccinate (UNII: I9PJ0O6294)
butylene glycol (UNII: 3XUS85K0RA)
magnesium sulfate anhydrous (UNII: ML30MJ2U7I)
aluminum oxide (UNII: LMI26O6933)
PEG-9 polydimethylsiloxyethyl dimethicone (UNII: TYP81E471F)
silicon dioxide (UNII: ETJ7Z6XBU4)
talc (UNII: 7SEV7J4R1U)
ferric oxide red (UNII: 1K09F3G675)
sorbitan isostearate (UNII: 01S2G2C1E4)
stearalkonium hectorite (UNII: OLX698AH5P)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
caprylyl glycol (UNII: 00YIU5438U)
propylene carbonate (UNII: 8D08K3S51E)
dimethicone (UNII: 92RU3N3Y1O)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
1,2-hexanediol (UNII: TR046Y3K1G)
coconut oil (UNII: Q9L0O73W7L)
gardenia taitensis flower (UNII: T0OCU8201Y)
tocopherol (UNII: R0ZB2556P8)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-083-01	1 in 1 CARTON
1		30 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	09/01/2015

RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   MEDIUM
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
isododecane (UNII: A8289P68Y2)
cyclomethicone 5 (UNII: 0THT5PCI0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
nylon-12 (UNII: 446U8J075B)
dipropylene glycol (UNII: E107L85C40)
medium-chain triglycerides (UNII: C9H2L21V7U)
cyclomethicone 6 (UNII: XHK3U310BA)
aluminum starch octenylsuccinate (UNII: I9PJ0O6294)
butylene glycol (UNII: 3XUS85K0RA)
magnesium sulfate anhydrous (UNII: ML30MJ2U7I)
aluminum oxide (UNII: LMI26O6933)
PEG-9 polydimethylsiloxyethyl dimethicone (UNII: TYP81E471F)
silicon dioxide (UNII: ETJ7Z6XBU4)
talc (UNII: 7SEV7J4R1U)
ferric oxide red (UNII: 1K09F3G675)
sorbitan isostearate (UNII: 01S2G2C1E4)
stearalkonium hectorite (UNII: OLX698AH5P)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
caprylyl glycol (UNII: 00YIU5438U)
propylene carbonate (UNII: 8D08K3S51E)
dimethicone (UNII: 92RU3N3Y1O)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
1,2-hexanediol (UNII: TR046Y3K1G)
coconut oil (UNII: Q9L0O73W7L)
gardenia taitensis flower (UNII: T0OCU8201Y)
tocopherol (UNII: R0ZB2556P8)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-084-01	1 in 1 CARTON
1		30 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	09/01/2015

RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   TAN
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
isododecane (UNII: A8289P68Y2)
cyclomethicone 5 (UNII: 0THT5PCI0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
nylon-12 (UNII: 446U8J075B)
dipropylene glycol (UNII: E107L85C40)
medium-chain triglycerides (UNII: C9H2L21V7U)
cyclomethicone 6 (UNII: XHK3U310BA)
aluminum starch octenylsuccinate (UNII: I9PJ0O6294)
butylene glycol (UNII: 3XUS85K0RA)
magnesium sulfate anhydrous (UNII: ML30MJ2U7I)
aluminum oxide (UNII: LMI26O6933)
PEG-9 polydimethylsiloxyethyl dimethicone (UNII: TYP81E471F)
silicon dioxide (UNII: ETJ7Z6XBU4)
talc (UNII: 7SEV7J4R1U)
ferric oxide red (UNII: 1K09F3G675)
sorbitan isostearate (UNII: 01S2G2C1E4)
stearalkonium hectorite (UNII: OLX698AH5P)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
caprylyl glycol (UNII: 00YIU5438U)
propylene carbonate (UNII: 8D08K3S51E)
dimethicone (UNII: 92RU3N3Y1O)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
1,2-hexanediol (UNII: TR046Y3K1G)
coconut oil (UNII: Q9L0O73W7L)
gardenia taitensis flower (UNII: T0OCU8201Y)
tocopherol (UNII: R0ZB2556P8)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-085-01	1 in 1 CARTON
1		30 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	09/01/2015

RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   DEEP
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
isododecane (UNII: A8289P68Y2)
cyclomethicone 5 (UNII: 0THT5PCI0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
nylon-12 (UNII: 446U8J075B)
dipropylene glycol (UNII: E107L85C40)
medium-chain triglycerides (UNII: C9H2L21V7U)
cyclomethicone 6 (UNII: XHK3U310BA)
aluminum starch octenylsuccinate (UNII: I9PJ0O6294)
butylene glycol (UNII: 3XUS85K0RA)
magnesium sulfate anhydrous (UNII: ML30MJ2U7I)
aluminum oxide (UNII: LMI26O6933)
PEG-9 polydimethylsiloxyethyl dimethicone (UNII: TYP81E471F)
silicon dioxide (UNII: ETJ7Z6XBU4)
talc (UNII: 7SEV7J4R1U)
ferric oxide red (UNII: 1K09F3G675)
sorbitan isostearate (UNII: 01S2G2C1E4)
stearalkonium hectorite (UNII: OLX698AH5P)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
caprylyl glycol (UNII: 00YIU5438U)
propylene carbonate (UNII: 8D08K3S51E)
dimethicone (UNII: 92RU3N3Y1O)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
1,2-hexanediol (UNII: TR046Y3K1G)
coconut oil (UNII: Q9L0O73W7L)
gardenia taitensis flower (UNII: T0OCU8201Y)
tocopherol (UNII: R0ZB2556P8)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-086-01	1 in 1 CARTON
1		30 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	09/01/2015

Labeler - Tarte, Inc (027905186)