FDA.reportPublic FDA data

Body Melt

Manufacturer
Make2Give LLC
Effective date
2020-04-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:28:12

Label at a glance#

ProductBody Melt
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

• helps prevent sunburn • Retains SPF after 80 minutes of swimming or sweating • 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 and spread evenly 15 minutes before sun exposure and as needed. • 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 protecti...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6%

Zinc Oxide 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn

• Retains SPF after 80 minutes of swimming or sweating
• 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.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor

OTC - STOP USE SECTION

if a rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally and spread evenly 15 minutes before sun exposure and as needed.
• 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- 2pm • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Extract, Beeswax, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Helianthus Annuus (Sunflower) Oil, Persea Gratissima (Avocado) Oil, Punica Granatum (Pomegranate) Extract, Tocopherol (Vitamin E).

Other Information

SPL UNCLASSIFIED SECTION

Protect the product from excessive heat and direct sun. High sun protection product
• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. 

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label9Label9Label10Label10

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75796-00575796-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
YELLOW WAX2ZA36H0S2VIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
CARROTL56Z1JK48BIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
AVOCADO OIL6VNO72PFC1IACT
POMEGRANATE56687D1Z4DIACT
TOCOPHEROLR0ZB2556P8IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
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
ebf57797-3aef-270b-e053-2995a90ae13265806d2b-62c3-4195-bc48-5eebe63c21ee2022-10-26WarningsExact identifier
spl set id: 65806d2b-62c3-4195-bc48-5eebe63c21ee

Reported adverse events (FAERS/openFDA)#

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