Lemongrass Spa Products SPF 45 Tinted Sunscreen

Lemongrass Spa Products SPF 45 Tinted Mineral Sunscreen by

Drug Labeling and Warnings

Lemongrass Spa Products SPF 45 Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Lemongrass Spa Products, LLC, Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEMONGRASS SPA PRODUCTS SPF 45 TINTED MINERAL SUNSCREEN- zinc oxide lotion 
Lemongrass Spa Products, LLC

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Lemongrass Spa Products SPF 45 Tinted Sunscreen

Zinc Oxide 19%

Sunscreen.

Helps prevent sunburn.

For external use only.

Do no use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

If product is swallowed, get medical help or contact a Poison Control Center right away.

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at lease every 2 hours.

For children under 6 months of age: ask a doctor.

Aloe Barbadensis (Aloe) Leaf Juice*, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Curcuma Longa (Turmeric) Root Extract*, Deionized Water, Diisostearoyl Polyglycery-3 Dimer Dilinoleate, Ethyl Lauroyl Arginate HCl, Extracts of Alaria Esculenta (Wakame Seaweed), Camelia Sinensis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Olea Europa (Olive) Leaf* in Cocos Nucifera (Coconut) Oil, Iron Oxides (CI 77492, CI 77491, CI 77499), Isoamyl Laurate, Jojoba Esters, Mica, Mixed Tocopherols, Olive Squalane Oil, Polyglyceryl-3 Oleate, Polyhydroxystearic Acid, Olive Squalane Oil, Polyglceryl-3 Oleate, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Vegetarian Glycerin, Xanthan Gum, *ORGANIC INGREDIENTS

LEMONGRASS SPA PRODUCTS SPF 45 TINTED MINERAL SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70553-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MICA (UNII: V8A1AW0880)
COCONUT OIL (UNII: Q9L0O73W7L)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HOLY BASIL LEAF (UNII: SCJ765569P)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TURMERIC (UNII: 856YO1Z64F)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70553-021-02	75 mL in 1 TUBE; Type 0: Not a Combination Product	03/29/2024	03/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/29/2024	03/29/2024

Labeler - Lemongrass Spa Products, LLC (069703885)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(70553-021)

Revised: 3/2024

Document Id: 14bcbce6-6bcb-2032-e063-6394a90a25c2

34390-5

Set id: 147deea3-172e-bc6f-e063-6294a90a10b3

Version: 2

Effective Time: 20240328