Body Conditioner by Make2Give LLC Body Conditioner

Body Conditioner by

Drug Labeling and Warnings

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

Drug Details [pdf]

BODY CONDITIONER- 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 Conditioner

Drug Facts

Active Ingredients

Titanium Dioxide 4%

Zinc Oxide 5%

Purpose

Sunscreen

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

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 at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
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

Acrylates Copolymer, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter), C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetyl Alcohol, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera lndica (Mango) Butter, Parfum (Natural Fragrance), Punica Granatum (Pomegranate) Extract, Saccharide lsomerate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

Other Information

Protect the product from excessive heat and direct sun.

Package Labeling:

BODY CONDITIONER 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75796-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATERMELON (UNII: 231473QB6R)
CARROT (UNII: L56Z1JK48B)
COCONUT OIL (UNII: Q9L0O73W7L)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
MANGO (UNII: I629I3NR86)
POMEGRANATE (UNII: 56687D1Z4D)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75796-004-01	88 mL in 1 JAR; Type 0: Not a Combination Product	06/01/2020	06/01/2020

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

Labeler - Make2Give LLC (023910159)

Revised: 11/2020

Document Id: b3da87c0-b13f-5c9b-e053-2995a90a642f

34390-5

Set id: bd9b9948-7f08-4ab4-a8a8-f7691b98e568

Version: 3

Effective Time: 20201111