Natural Tanning & Body Oil SPF6

Natural Tanning and Body Oil SPF6 by

Drug Labeling and Warnings

Natural Tanning and Body Oil SPF6 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 SPF6- octocrylene, octinoxate, avobenzone oil 
Bali Body Pty Ltd

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Natural Tanning & Body Oil SPF6

Product Information / Drug Facts

Directions:

Shake well before use. Apply liberally 15 minutes before sun exposure. Children under 6 months old: Ask a doctor. Re-apply every 2 hours. Use water-resistant sunscreen if swimming or sweating. Store in a cool dry place.

Warnings / Cautions / Sun safety:

Spending time in the sun increases your risk of skin cancer or early skin ageing. This product has been shown only to prevent sunburn, not skin cancer or early skin ageing.

Do not use 

on damaged or broken skin. 

When using this product

keep out of eyes. Rinse with water to remove. 

Stop use and ask a doctor

if rash occurs. Always wear a hat, protective clothing and sunglasses.

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 3%,
Octinoxate 3%,
Avobenzone 1%.

Purpose:

Sunsreen

Inactive ingredients:

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

Package Labeling:

NATURAL TANNING AND BODY OIL SPF6 
octocrylene, octinoxate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	10 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)
C15-23 ALKANE (UNII: J3N6X3YK96)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0001-1	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	01/01/2023

Labeler - Bali Body Pty Ltd (757840223)

Revised: 10/2023

Document Id: 070df417-0bd8-16dd-e063-6294a90af229

34390-5

Set id: c7214adb-30e8-4648-87c3-43c465d29186

Version: 3

Effective Time: 20231006