Body Melt by Make2Give LLC Body Melt

Body Melt by

Drug Labeling and Warnings

Body Melt by is a Otc medication manufactured, distributed, or labeled by Make2Give LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BODY MELT- titanium dioxide, zinc oxide cream 
Make2Give LLC

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.

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Body Melt

Drug Facts

Active Ingredients

Titanium Dioxide 6%

Zinc Oxide 6%

Purpose

Sunscreen

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

Warnings

For external use only.

When using this product

keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor

if a rash or irritation develops and lasts.

Keep out of reach of children.

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

Directions

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

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

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:

BODY MELT 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75796-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
YELLOW WAX (UNII: 2ZA36H0S2V)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
CARROT (UNII: L56Z1JK48B)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
AVOCADO OIL (UNII: 6VNO72PFC1)
POMEGRANATE (UNII: 56687D1Z4D)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75796-005-01	59 mL in 1 JAR; Type 0: Not a Combination Product	06/01/2020	06/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2020	06/30/2022

Labeler - Make2Give LLC (023910159)

Revised: 10/2022

Document Id: ebf57797-3aef-270b-e053-2995a90ae132

34390-5

Set id: 65806d2b-62c3-4195-bc48-5eebe63c21ee

Version: 3

Effective Time: 20221026