BALI BODY SPF PINEAPPLE TANNING OIL (OCTINOXATE, OCTOCRYLENE CREAM) OIL [BALI BODY PTY LTD]

BALI BODY SPF PINEAPPLE TANNING OIL (OCTINOXATE, OCTOCRYLENE CREAM) OIL [BALI BODY PTY LTD]
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NDC	70630-1801-1
Set ID	6ce6de0e-0b87-3997-e053-2991aa0a32c8
Category	HUMAN OTC DRUG LABEL
Packager	Bali Body Pty Ltd
Generic Name
Product Class
Product Number
Application Number	PART352

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ACTIVE INGREDIENT

Octinoxate 2.5%

Octocrylene 2.5%
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
PURPOSE

A tanning and body oil.

Provides SPF 6 protection.
INDICATIONS & USAGE

Shake well before use. Apply liberaly 15 minutes before sun exposure.

Children under 6 months: Ask a doctor.

Reapply every 2 hours.

Use water-resistant sunscreen if swimming or sweating.

Store in a cool dry place.
INACTIVE INGREDIENT
- Grape seed oil;
- Coconut oil;
- Soybean oil;
- Sweet almond oil;
- Pineapple; and
- Vitamin E.
WARNINGS

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

This product has ben 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.
DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BALI BODY SPF PINEAPPLE TANNING OIL SPF 6
octinoxate, octocrylene cream oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70630-1801
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 mg in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SOYBEAN OIL (UNII: 241ATL177A)
PINEAPPLE (UNII: 2A88ZO081O)
COCONUT OIL (UNII: Q9L0O73W7L)
ALMOND OIL (UNII: 66YXD4DKO9)
GRAPE SEED OIL (UNII: 930MLC8XGG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70630-1801-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/21/2018

Labeler - Bali Body Pty Ltd (757840223)

Registrant - Bali Body Pty Ltd (757840223)

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