Peach Tanning Oil SPF15 by Bali Body Pty Ltd Peach Tanning Oil SPF15

Peach Tanning Oil SPF15 by

Drug Labeling and Warnings

Peach Tanning Oil SPF15 by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PEACH TANNING OIL SPF15- octocrylene, octinoxate, avobenzone oil 
Bali Body Pty Ltd

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.

----------

Peach Tanning Oil SPF15

Product Information / Drug Facts

Directions:

Shake well before use. Apply liberally 20 minutes before sun exposure. Re-apply your BB every 1-2 hours, after swimming or exercise..

Warnings / Cautions / Sun safety:

When using this product

keep out of eyes. If contact occurs rinse with water to remove. 

Stop use and seek medical advise

if rash occurs. Wear sun-smart options such as hat and sunglasses.

Do not use

on damaged or broken skin. Can aid in the prevention of premature skin ageing.

Keep out of reach of children.

Use:

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active ingredients:

Octocrylene 5%,
Octinoxate 5%,
Avobenzone 2%.

Purpose:

Sunsreen

Inactive ingredients:

Vitis Vinifera (Grape) Seed Oil, Prunus Amygdalus (Sweet Almond) Oil, Cocos Nucifera (Coconut) Oil, Octocrylene, Ethylhexyl Methoxycinnamate, Dicaprylyl Carbonate, Hydrogenated Soy Polyglyceride, Butyl Methoxydibenzoylmethane, Prunus Persica (Peach)Kernel Oil, Glycine Soja (Soybean) Oil, Tocopherol, C15-23 Alkane, BHT, Fragrance (Parfum), Benzyl Alcohol*

Package Labeling:

PEACH TANNING OIL SPF15 
octocrylene, octinoxate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GRAPE SEED OIL (UNII: 930MLC8XGG)
ALMOND OIL (UNII: 66YXD4DKO9)
COCONUT OIL (UNII: Q9L0O73W7L)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PERSIC OIL (UNII: 5M26W7T072)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
C15-23 ALKANE (UNII: J3N6X3YK96)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0010-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2021	11/01/2021

Labeler - Bali Body Pty Ltd (757840223)

Revised: 12/2021

Document Id: d28f0af0-8942-05b0-e053-2995a90af894

34390-5

Set id: dbb6eafe-2485-4ea8-9b3f-941ff8d6e1ec

Version: 2

Effective Time: 20211207