Tropical Mint Value Broad Spectrum SPF 15 Lip Moisturi by Raining Rose, Inc / Raining Rose, Inc.

Tropical Mint Value Broad Spectrum SPF 15 Lip Moisturi by

Drug Labeling and Warnings

Tropical Mint Value Broad Spectrum SPF 15 Lip Moisturi by is a Otc medication manufactured, distributed, or labeled by Raining Rose, Inc, Raining Rose, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TROPICAL MINT VALUE BROAD SPECTRUM SPF 15 LIP MOISTURI- tropical mint value broad spectrum spf 15 lip moisturizer stick 
Raining Rose, Inc

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Avobenzone 2.0%

Octinoxate 7.5%

Sunscreen

For external use only.

on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

Keep out of eyes. Rinse well with water to remove.

Keep out of reach of children.

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

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 of age: Ask a doctor

Coconut Oil, Sunflower Oil, Shea Butter, Ozokerite Wax, Beeswax, Flavor, Cornmint Oil, Stevia, Tocopherol, Soybean Oil.

Helps prevent sunburn

TROPICAL MINT VALUE BROAD SPECTRUM SPF 15 LIP MOISTURI 
tropical mint value broad spectrum spf 15 lip moisturizer stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0578
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.09 g  in 4.25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.32 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
SOYBEAN OIL (UNII: 241ATL177A)
WHITE WAX (UNII: 7G1J5DA97F)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
COCONUT OIL (UNII: Q9L0O73W7L)
CERESIN (UNII: Q1LS2UJO3A)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0578-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product	05/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/22/2024	02/01/2025

Labeler - Raining Rose, Inc (083819404)

Registrant - Raining Rose, Inc. (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc		083819404	manufacture(65692-0578)

Revised: 2/2025

Document Id: 2dcc4b6e-d1ad-bd6b-e063-6294a90a2011

34390-5

Set id: 1910aa68-b417-1b9f-e063-6394a90a0215

Version: 2

Effective Time: 20250210