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

VANILLA MINT SPF 15 BROAD SPECTRUM LIP BALM- octisalate, avobenzone, octocrylene 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 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*, Rosemary Extract, Vitamin E, Aloe Vera. * Organic

Package Label

C10424 SPF 15 Vanilla Mint
(click image for full-size original)

VANILLA MINT SPF 15 BROAD SPECTRUM LIP BALM
vanilla mint spf 15 broad spectrum lip balm stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0537
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 0.21 g in 4.25 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.09 g in 4.25 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.06 g in 4.25 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.28 g in 4.25 g
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL
TOCOPHEROL
ROSEMARY
WHITE WAX
OLIVE OIL
CANNABIS SATIVA SEED OIL
ALOE VERA LEAF
Product Characteristics
Color Score
Shape Size
Flavor VANILLA (Mint) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65692-0537-1 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: 06/2020 Raining Rose, Inc

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