TULIP DEW SUNSCREEN- zinc oxide lotion

Tulip Dew Sunscreen by

Drug Labeling and Warnings

Tulip Dew Sunscreen by is a Otc medication manufactured, distributed, or labeled by Bloomeffects, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 12%

Purpose

Sunscreen

Uses

• Helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer & early skin aging caused by the sun. Directions

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.

Stop use & ask a doctor

• if skin rash occurs.

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

• REAPPLY : use a water-resistant sunscreen if swimming or sweating

• at least every 2 hours

• 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 & other sun protection measures including: Sun Protection Measures 

• limit your 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.

• Shake well

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Water (Aqua), C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Tridecyl Salicylate, Propanediol, Polyglyceryl-4 Disostearate/Polyhydroxystearates/Sebacate, Niacinamide, Methylpropanediol, Silica, Nylon-12, Coco-Caprylate, Tulipa Gesneriana/Kaurmanniana Meristem Cell Lysate Filtrate Extract, Helianthus Annuus Extract, Glycerin, Sodium Hyaluronate, Sodium Lactate, Bisabolol, Allantoin, Oryza Sativa Bran Extract, Terminalia Ferdinandiana Fruit Extract, Podocarpus Elatus Fruit Extract, Pleiogynium Timoriense Fruit Extract, Lecithin, Hydrogenated Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Rosmarinus Officinalis Leaf Extract, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Methylheptyl Isostearate, Phenylpropanol, Tetrasodium Glutamate Diacetate, Sodium Gluconate, Pentylene Glycol, Sodium Hydroxide, Phenethyl Alcohol, Potassium Sorbate, Alcohol, Hamamelis Virginiana Water, Citric Acid, CI 77499, CI 77492, CI 77491.

Package Labeling:

INGREDIENTS AND APPEARANCE

TULIP DEW SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82548-4530
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
NIACINAMIDE (UNII: 25X51I8RD4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
COCO-CAPRYLATE (UNII: 4828G836N6)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM LACTATE (UNII: TU7HW0W0QT)
LEVOMENOL (UNII: 24WE03BX2T)
ALLANTOIN (UNII: 344S277G0Z)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
PODOCARPUS ELATUS FRUIT (UNII: R4N1M6CZCY)
PLEIOGYNIUM TIMORIENSE FRUIT (UNII: AF3VFG6MLV)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
ROSEMARY (UNII: IJ67X351P9)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
PHENYLPROPANOL (UNII: 0F897O3O4M)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82548-4530-1	1 in 1 CARTON	05/01/2022
1		55 mL in 1 BOTTLE, PUMP; 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	05/01/2022

Labeler - Bloomeffects, Inc. (096991853)