FDA.reportPublic FDA data

Raw Elements Lip Rescue 30 Broad Spectrum SPF 30

Manufacturer
Raw Elements LLC
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:42

Label at a glance#

ProductRaw Elements Lip Rescue 30 Broad Spectrum SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

• apply liberally 15 minutes before sun exposure, reapply:       after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 of 15 or higher and other sun protection measures including:   • limit time...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 22.75%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical helps or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure, reapply:

      after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

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 of 15 or higher and other sun protection measures including:

  • limit time in the sun especially from 10 am - 2 pm   • wear long-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Camellia Sinensis Leaf Extract (Organic Green Tea), Camellia Sinensis Leaf Extract (Organic Black Tea), Cannabis Sativa Seed Oil (Organic Hemp Seed Oil), Cera Alba (Organic Beeswax), Coffea Arabica Seed Extract (Oranic Coffee Bean), Euphorbia Cerifera Cera (Natural Candelilla Wax), Helianthus Annuus Seed Oil (Organic Sunflower Oil), Iron Oxide, Mangifera Indica Seed Butter (Natural Mango Butter), Rosmarinus Officinalis Leaf Oil (Natural Rosemary), Theobroma Cacao Seed Butter (Organic Cocoa Butter), Tocopherol

Other information

SPL UNCLASSIFIED SECTION

• pretect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-442-6676

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  1. new labelnew label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70680-301-01Raw Elements Lip Rescue 30 Broad Spectrum SPF 304.25 g in 1 TUBECREAM4.254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70680-301RAW ELEMENTS LIP RESCUE 30 BROAD SPECTRUM SPF 30 (ZINC OXIDE) CREAM [RAW ELEMENTS LLC]4Current NDC, Legacy NDC, 1 package rows20231110_74b8eac3-4bc6-430b-b4b9-eabe3280d7af.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70680-30170680-301-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
WHITE WAX7G1J5DA97FIACT
SUNFLOWER OIL3W1JG795YIIACT
FERRIC OXIDE RED1K09F3G675IACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
ROSEMARY OIL8LGU7VM393IACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raw Elements Lip Rescue 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC74b8eac3-4bc6-430b-b4b9-eabe3280d7af2023-11-09WarningsExact identifier
ndc (package): 70680-301-01
ndc (product): 70680-301
ndc11 (package): 70680030101
spl id: 09c29a75-14a4-1335-e063-6394a90a7f27
spl set id: 74b8eac3-4bc6-430b-b4b9-eabe3280d7af

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.