TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30- brightening skin tint lotion

TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Octisalate 5%

Purpose

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. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove.

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.

Directions

Apply liberally 15 minutes before sun exposure. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am – 2 pm, wear long sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor

Inactive Ingredients

Aqua/Water/Eau, C9-12 Alkane , Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Triethylhexanoin, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Isododecane, Silica, Butylene Glycol, Disteardimonium Hectorite, Trimethylsiloxysilicate, VP/Eicosene Copolymer, Glycerin, Argania Spinosa Kernel Oil, Tocopheryl Acetate, VP/Hexadecene Copolymer, Octyldodecyl Neopentanoate, Sodium Chloride, Magnesium Sulfate, Boron Nitride, Sorbitan Oleate, Polyglycerin-6, Caesalpinia Spinosa Fruit Extract, Octyldodecanol, Safflower oil/ Palm oil aminopropanediol esters , Mica , Lactococcus Ferment Lysate, Alpha-Glucan Oligosaccharide, Hydrogenated Lecithin, Bisabolol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Simethicone, Kappaphycus Alvarezii Extract, Pongamia Glabra Seed Oil , Beta Vulgaris (Beet) Root Extract, Cystoseira Tamariscifolia Extract, Inulin, Niacinamide, Tocopherol, Tetrahexyldecyl Ascorbate, Ascorbyl Palmitate, Lactic Acid, Polymnia Sonchifolia Root Juice, Lactobacillus Ferment, Curcuma Longa (Turmeric) Root Extract, Maltodextrin, Ceramide NP, Dunaliella Salina Extract , Haematococcus Pluvialis Extract , Acacia Seyal Gum Extract, Lactobacillus, Ethylhexylglycerin, Aluminum Hydroxide, Sodium Hyaluronate, Citric Acid, 1,2-Hexanediol, Caprylyl Glycol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

PRINCIPLE DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 
brightening skin tint lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ACACIA SEYAL WHOLE (UNII: 0H7YR6DN6P)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TURMERIC (UNII: 856YO1Z64F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BETA VULGARIS (UNII: 4G174V5051)
WATER (UNII: 059QF0KO0R)
LACTIC ACID (UNII: 33X04XA5AT)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
LACTOCOCCUS LACTIS (UNII: F1A0PSN10V)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
SAFFLOWER (UNII: 4VBL71TY4Y)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
SMALLANTHUS SONCHIFOLIUS ROOT JUICE (UNII: M9S7HX36CT)
CERAMIDE NP (UNII: 4370DF050B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
OCTYLDODECANOL (UNII: 461N1O614Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)
CYSTOSEIRA TAMARISCIFOLIA (UNII: HRU0KH4VFH)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
ARGAN OIL (UNII: 4V59G5UW9X)
SORBITAN (UNII: 6O92ICV9RU)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
KARUM SEED OIL (UNII: 62160PU6FJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERIN-6 (UNII: M51422LRAM)
PENTAERYTHRITOL 3,5-DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE (UNII: A8VXR0397K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
INULIN (UNII: JOS53KRJ01)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BORON NITRIDE (UNII: 2U4T60A6YD)

Product Characteristics
Color	brown (SHADE 20 -TAN NEUTRAL-COOL)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-208-01	1 in 1 CARTON	08/01/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/01/2022

Labeler - MANA PRODUCTS, INC (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		032870270	manufacture(59735-208)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		078870292	manufacture(59735-208)