FDA.reportPublic FDA data

Raw Elements Baby+Kids Broad Spectrum SPF30 Lotion

Manufacturer
Raw Elements LLC
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:46

Label at a glance#

ProductRaw Elements Baby Kids Broad Spectrum SPF30
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 in the su...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Zinc Oxide 25%

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 help 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

Helianthus Annuus (Organic Sunflower) Seed Oil, Cera Alba (Organic Beeswax), Cocos Nucifera (Organic Coconut) Oil, Theobroma Cacao (Organic Cocoa) Seed Butter, Calendula Officinalis (Organic Calendula) Flower Extract, Organic Chamomilla Recutita (Organic Chamomile) Flower Extract, Rosmarinus Officinalis (Natural Rosemary) Leaf Extract, Tocopherol (Natural Sunflower Vitamin E)

Other information

SPL UNCLASSIFIED SECTION

  • protect 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

Label5Label5Label6Label6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70680-307-00Raw Elements Baby Kids Broad Spectrum SPF3085 g in 1 CANLOTION852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70680-307RAW ELEMENTS BABY KIDS BROAD SPECTRUM SPF30 (ZINC OXIDE) LOTION [RAW ELEMENTS LLC]2Current NDC, Legacy NDC, 1 package rows20231110_fda8fce8-a164-45b5-b6ca-b1efce474089.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70680-30770680-307-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ROSEMARYIJ67X351P9IACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB

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 Baby Kids Broad Spectrum SPF30ZINC OXIDERaw Elements LLCfda8fce8-a164-45b5-b6ca-b1efce4740892023-11-09WarningsExact identifier
ndc (package): 70680-307-00
ndc (product): 70680-307
ndc11 (package): 70680030700
spl id: 09c28e4c-ced2-8f33-e063-6294a90a580e
spl set id: fda8fce8-a164-45b5-b6ca-b1efce474089

Reported adverse events (FAERS/openFDA)#

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