BS SPF 15 Caribbean Breeze Lip balm

SPF 15 Broad Spectrum Flavored Lip Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPF 15 BROAD SPECTRUM FLAVORED LIP BALM- spf 15 broad spectrum flavored lip balm stick 
Raining Rose, Inc

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BS SPF 15 Caribbean Breeze Lip balm

Active Ingredients

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Purpose

Sunscreen

Warnings

For external use only

Do not use

on damaged or broken skin.

Stop Use and ask a doctor if

Rash Occurs

When Using this Product

Keep out of eyes. Rinse well 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

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours
Children under 6 months of age: Ask a doctor

Inactive ingredients:

Sunflower oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Soybean Oil, Sunflower Seed Oil Glycerides, Rosemary Extract, Vitamin E, Aloe Extract, Canola Oil. * Organic

Apply liberally 15 minutes before sun exposure

Helps prevent sunburn

Package Label

SPF 15 BROAD SPECTRUM FLAVORED LIP BALM 
spf 15 broad spectrum flavored lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0582
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.21 g  in 4.25 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.09 g  in 4.25 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.06 g  in 4.25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.28 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
WHITE WAX (UNII: 7G1J5DA97F)
OLIVE OIL (UNII: 6UYK2W1W1E)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANOLA OIL (UNII: 331KBJ17RK)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL MONO/DIGLYCERIDES (UNII: HS7EB0C1ZH)

Product Characteristics
Color		Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0582-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product	02/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/17/2020	12/31/2025

Labeler - Raining Rose, Inc (083819404)

Revised: 3/2026

Document Id: 4cacd4cc-e95a-aa5c-e063-6294a90af5bc

34390-5

Set id: 23faa6be-4d1e-4dee-e063-6394a90a292c

Version: 5

Effective Time: 20260310