BROAD SPECTRUM SPF 15 SUNSCREEN FRESH BERRY LIP BALM- road spectrum spf 15 sunscreen fresh berry lip balm stick

Broad Spectrum SPF 15 Sunscreen Fresh Berry Lip Balm by

Drug Labeling and Warnings

Broad Spectrum SPF 15 Sunscreen Fresh Berry Lip Balm 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]

ACTIVE INGREDIENT

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

Stop use and ask a doctor if rash occurs

WHEN USING

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.

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

Apply liberally 15 mintues before sun exposure

INDICATIONS & USAGE

Helps prevent sunburn

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 15 SUNSCREEN FRESH BERRY LIP BALM 
road spectrum spf 15 sunscreen fresh berry lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0576
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
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.09 g  in 4.25 g

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

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0576-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product	04/23/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/23/2024

Labeler - Raining Rose, Inc (083819404)

Registrant - Raining Rose, Inc. (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc.		083819404	manufacture(65692-0576)