PEACH TANNING OIL SPF 15- 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 15

Peach SPF 15

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

BHT

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.

PEACH TANNING OIL SPF 15 
octinoxate, octocrylene cream oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-1904
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALMOND OIL (UNII: 66YXD4DKO9)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PERSIC OIL (UNII: 5M26W7T072)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
C15-23 ALKANE (UNII: J3N6X3YK96)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
SOYBEAN OIL (UNII: 241ATL177A)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-1904-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/201911/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/201911/30/2021
Labeler - Bali Body Pty Ltd (757840223)
Registrant - Bali Body Pty Ltd (757840223)

Revised: 1/2021
Document Id: b83980c5-220f-5305-e053-2a95a90ab705
Set id: 964bc2c8-afdf-522f-e053-2995a90a5444
Version: 3
Effective Time: 20210106
 
Bali Body Pty Ltd