Vanilla Mint Broad Spectrum SPF 15 Lip Moisturizer: Package Insert and Label Information

VANILLA MINT BROAD SPECTRUM SPF 15 LIP MOISTURIZER- avobenzone and octinoxate stick
Raining Rose, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Avobenzone 2.0%

Octinoxate 7.5%

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:

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

Package Label

C37801_4imprint Vanilla mint SPF 15 BS Lip Moisturizer
(click image for full-size original)

VANILLA MINT BROAD SPECTRUM SPF 15 LIP MOISTURIZER
vanilla mint spf 15 broad spectrum lip moisturizer stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0553
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.09 g in 4.25 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.32 g in 4.25 g
Inactive Ingredients
Ingredient Name Strength
PEPPERMINT OIL
SOYBEAN OIL
COCONUT OIL
SUNFLOWER OIL
TOCOPHEROL
WHITE WAX
SHEA BUTTER
CERESIN
STEVIA REBAUDIUNA LEAF
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65692-0553-1 4.25 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/17/2020
Labeler — Raining Rose, Inc (083819404)

Revised: 09/2020 Raining Rose, Inc

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