Grape Soda SPF 15 Broad Spectrum Lip Balm: Package Insert and Label Information

GRAPE SODA 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, Tocopherol, Stevia*, Aloe Extract, Canola Oil, Soybean Oil, Sunflower Seed Oil Glycerides. * Organic

Package Label

GRAPE SODA SPF 15 BROAD SPECTRUM LIP BALM grape soda spf 15 broad spectrum lip balm stick

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0508 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 STEVIA LEAF SUNFLOWER OIL TOCOPHEROL ROSEMARY WHITE WAX OLIVE OIL CANNABIS SATIVA SEED OIL ALOE VERA LEAF CANOLA OIL SOYBEAN OIL SUNFLOWER OIL MONO/DIGLYCERIDES

Product Characteristics Color Score Shape Size Flavor FRUIT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65692-0508-1 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: 02/2021 Raining Rose, Inc