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NDC 65692-0201-01 Vanilla Mint Lip .12; .32; .21; .1; .25 g/4.25g; g/4.25g; g/4.25g; g/4.25g; g/4.25g Details

Vanilla Mint Lip .12; .32; .21; .1; .25 g/4.25g; g/4.25g; g/4.25g; g/4.25g; g/4.25g

Vanilla Mint Lip is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Raining Rose, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	65692-0201
Product ID	65692-0201_b0907da1-8d35-48cd-adc9-f81b00e2a10c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Vanilla Mint Lip
Proprietary Name Suffix	SPF 30 Balm
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	.12; .32; .21; .1; .25
Active Ingredient Units	g/4.25g; g/4.25g; g/4.25g; g/4.25g; g/4.25g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	Raining Rose, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 65692-0201-01 (65692020101)

Pricing Information	N/A
NDC Package Code	65692-0201-1
Billing NDC	65692020101
Package	4.25 g in 1 CONTAINER (65692-0201-1)
Marketing Start Date	2016-12-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 76905526-dc55-46f0-b4a7-c910cf1297c6 Details

PEEL HERE FOR DRUG FACTSBROAD SPECTRUN SPF 30 SunscreenVanilla Mint Lip Balm - 0201

Active Ingredients:

Avobenzone 3.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 2.5%

Oxybenzone 6.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For External Use Only

Do not use

on damaged or broken skin

Stop use and as 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.

If swalowed, get medical help or call 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

Sun Protection Measures

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 and other protection measures including:

limit time in the sun, s\especially from 10a.m. - 2p.m.
wear long slessved shirts, pants, hat, and sunglasses.

Inactive Ingredients:

Sunflower oil*, beeswax, extra virgin olive oil*, flavor hemp seed oil*, rosemary extract, vitamin E, Aloe vera.

*Certified Organic

Other Information

Protect this product from excessive heart and direct sun.

Vanilla Mint Lip Balm SPF 30 product label

Dist. by: Raining Rose, Inc. Cedar Rapids, IA 52403

INGREDIENTS AND APPEARANCE

VANILLA MINT LIP SPF 30 BALM

avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65692-0201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.12 g in 4.25 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.32 g in 4.25 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.21 g in 4.25 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.10 g in 4.25 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.25 g in 4.25 g

Ingredient Name	Strength
Inactive Ingredients
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ROSEMARY (UNII: IJ67X351P9)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65692-0201-1	4.25 g in 1 CONTAINER; Type 0: Not a Combination Product	12/19/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/19/2016

Labeler - Raining Rose, Inc. (083819404)

Registrant - Raining Rose, Inc. (083819404)

Name	Address	ID/FEI	Business Operations
Establishment
Raining Rose, Inc.		083819404	manufacture(65692-0201) , label(65692-0201) , relabel(65692-0201) , repack(65692-0201)

Revised: 1/2017

Document Id: b0907da1-8d35-48cd-adc9-f81b00e2a10c

Set id: 76905526-dc55-46f0-b4a7-c910cf1297c6

Version: 1

Effective Time: 20170123