THE BOD GUARD INVISIBLE SUNSCREEN FOR BODY- avobenzone, homosalate, octisalate, and octocrylene gel

The Bod Guard by

Drug Labeling and Warnings

The Bod Guard by is a Otc medication manufactured, distributed, or labeled by Dune Suncare, Inc., Vegelabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredients

Avobenzone 2.0%
Homosalate 5.5%
Octisalate 4.5%
Octocrylene 4.0%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

• apply liberally and evenly 15 minutes before sun exposure
• reapply:
  • after 40 minutes of swimming or sweating.
  • at least every 2 hours
• children under 6 months of age: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10a.m.-2p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Trisiloxane, Alcohol, Dimethicone, 1,2-Hexanediol, Glycerin, Sodium Polycryloyldimethyl Taurate, Brassica Glycerides, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Caprylhydroxamic Acid, Polysilicone-11, Disodium EDTA, Erythritol, Fragrance, Tocopheryl Acetate, Butylene Glycol, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Hibiscus Sabdariffa Fruit Extract, Decyl Glucoside, t-Butyl Alcohol, Denatonium Benzoate

SPL UNCLASSIFIED SECTION

Dist. by: Dune Suncare, Los Angeles, CA 90292

PRINCIPAL DISPLAY PANEL - 250 ML Bottle Label

THE
BOD GUARD

INVISIBLE GEL
SUNSCARE FOR
BODY

BROAD SPECTRUM
SPF 30

WATER RESISTANT
(40 MINUTES)

DUNE
SUNCARE

SPF
30

72 Hour Hydration
Won't Clog Pores
Dermatologist
Approved
Scent: Sea Salt

250 ML

8.4 FL OZ

INGREDIENTS AND APPEARANCE

THE BOD GUARD   INVISIBLE SUNSCREEN FOR BODY
avobenzone, homosalate, octisalate, and octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82757-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.02 g  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.055 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.045 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.04 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)
Propanediol (UNII: 5965N8W85T)
Alcohol (UNII: 3K9958V90M)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
TRISILOXANE (UNII: 9G1ZW13R0G)
1,2-Hexanediol (UNII: TR046Y3K1G)
Glycerin (UNII: PDC6A3C0OX)
Aminomethylpropanol (UNII: LU49E6626Q)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Erythritol (UNII: RA96B954X6)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Butylene Glycol (UNII: 3XUS85K0RA)
Decyl Glucoside (UNII: Z17H97EA6Y)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82757-101-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/07/2022

Labeler - Dune Suncare, Inc. (049095642)

Establishment
Name	Address	ID/FEI	Business Operations
Vegelabs		117878620	MANUFACTURE(82757-101)