COCONUT VANILLA BODY BROAD SPECTRUM SPF 50- avobenzone, octisalate, octocrylene spray

Coconut Vanilla Body Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Coconut Vanilla Body Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by EAI-JR286, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Avobenzone 3.0, Octisalate 5.0% Octocrylene 8.0% Sunscreen

PURPOSE

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see D irections) decreases the risk of skin cancer and early skin aging caused by the sun

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctor if

• rash occurs

WARNINGS

For external use only

Flammable: Do not use near heat, flame, or while smoking

Do not use

• on damaged or broken skin

When using this product

• Keep out of eyes
• Rinse with water to remove
• Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

DOSAGE & ADMINISTRATION

Directions:

• Apply Liberally 15 minutes before sun exposure
• Hold 4 to 6 inches away from body when spraying
• Children under 6 months of age: Ask a doctor
• Do not spray directly on face and avoid breathing mist
• Spray on hand and and apply to face. Use in a well-ventillated area

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 value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.- 2p.m.

Wear long sleeved shirts, pants, hats and sunglasses

Reapply: After 80 minutes of swimming. Immediately after towel use or at least every 2 hours

INACTIVE INGREDIENT

Inactive ingredients: Alcohol Denat., Acrylates/ Octylacrylamide Copolymer, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Diisopropyl Adipate, Fragrance, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

May stain some fabrics

PRINCIPAL DISPLAY PANEL

vertra

50

Coconut Vanilla Body Spray

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

NET WT 5 OZ (142 g)

INGREDIENTS AND APPEARANCE

COCONUT VANILLA BODY BROAD SPECTRUM SPF 50 
avobenzone, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-094
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AVOCADO OIL (UNII: 6VNO72PFC1)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-094-01	142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	05/26/2023

Labeler - EAI-JR286, Inc (827896718)