Broad Spectrum Spf 15 Coconut Lip Balm Stick
FDA Label NDC 65692-0307

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose, Inc. for the product Broad Spectrum Spf 15 Coconut Lip Balm (NDC 65692-0307). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

Other Information

Protect this product from excessive heart and direct sun.

Otc - Active Ingredient

Active Ingredients: 

Zinc Oxide 3.5%

Otc - Purpose

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

Warnings

For External Use Only 

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - Stop Use


Stop use and as a doctor if rash occurs

Otc - When Using

  • When using this product keep out of eyes.  Rinse well with water to remove.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.

Dosage & Administration

Directions Apply liberally 15 minutes before sun exposure •
• Use a water resistant sunscreen if swimming or sweatinb •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, especially from 10a.m. - 2p.m. • wear
long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredient

Inactive Ingredients:  Organic Calendula, Organic Comfrey,

Organic Lavender, Organic Plantain and Organic Yarrow Infused in

Organic Extra Virgin Olive Oil with Organic Beeswax, Organic

Coconut Flavor and Non-GMO Vitamin E.

Product Package Labeling

UVA/UVB BROAD SPECTRUM SPF 15

Coconut Lip Balm

NET WT. 4.25g

DIST. BY ALLGOODPRODUCTS.COM, MORRO BAY, CA 93443            L000000

0307 (0307)

0307 (0307)

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