Natural Tanning & Body Oil SPF15

Natural Tanning and Body Oil SPF15 by

Drug Labeling and Warnings

Natural Tanning and Body 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]

NATURAL TANNING AND BODY OIL SPF15- octocrylene, octinoxate, avobenzone oil 
Bali Body Pty Ltd

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Natural Tanning & Body 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 6%,
Octinoxate 5%,
Avobenzone 2.5%.

Purpose:

Sunsreen

Inactive ingredients:

Vitis Vinifera (Grape) Seed Oil, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba)Seed Oil, Octocrylene, Ethylhexyl Methoxycinnamate, Dicaprylyl Carbonate, Butyl Methoxydibenzoylmethane, Hydrogenated Soy Polyglyceride, Glycine Soja (Soybean) Oil, Tocopherol (Vitamin E), BHT, Natural Coconut Fragrance, C15-23 Alkane.

Package Labeling:

NATURAL TANNING AND BODY OIL SPF15 
octocrylene, octinoxate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GRAPE SEED OIL (UNII: 930MLC8XGG)
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
C15-23 ALKANE (UNII: J3N6X3YK96)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0002-1	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 Drug	M020	01/01/2021	10/22/2024

Labeler - Bali Body Pty Ltd (757840223)

Revised: 10/2024

Document Id: 25119e0b-af34-6ead-e063-6394a90a42b1

34390-5

Set id: f0af793c-9f87-4502-9734-ac2468f857e4

Version: 3

Effective Time: 20241022