BALI BODY SPF 6 PEACH TANNING OIL- octinoxate, octocrylene cream oil

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)
Available from:
Bali Body Pty Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
70630-1920-1

BALI BODY SPF 6 PEACH TANNING OIL- octinoxate, octocrylene cream 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.

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Bali Body Peach Tanning Oil SPF 6

Octinoxate 2.5%

Octocrylene 2.5%

Avobenzone 1%

Keep out of reach of children.

A tanning and body oil.

Provides SPF 6 protection.

Shake well before use. Apply liberaly 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 cool dry place.

Vitis Vinifera (Grape) seed oil

Cocos Nucifera Oil (Coconut)

Sweet Almond Oil

Vitamin E

Dicaprylyl Carbonate

Hydrogenated Soy Polyglycerides

Soybean Oil

C15-23 Alkane

Benzyl Alcohol

Skin Cancer/Skin Ageing Alert: Spending time in the sun increases your risk of skin cancer and early

skin aging.

This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

Apply liberally 15 minutes before sun exposure.

BALI BODY SPF 6 PEACH TANNING OIL

octinoxate, octocrylene cream oil

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 6 30 -19 20

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

2.5 mg in 10 0 mL

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

2.5 mg in 10 0 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

1 mg in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

PERSIC O IL (UNII: 5M26 W7T0 72)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

C15-2 3 ALKANE (UNII: J3N6 X3YK9 6 )

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

GRAPE SEED O IL (UNII: 9 30 MLC8 XGG)

SO YBEAN O IL (UNII: 241ATL177A)

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

Packag ing

Bali Body Pty Ltd

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 6 30 -19 20 -1 10 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /17/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 6 /17/20 19

Labeler -

Bali Body Pty Ltd (757840223)

Registrant -

Bali Body Pty Ltd (757840223)

Revised: 8/2019

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