Moisturising Sunscreen SPF15

Moisturising Sunscreen SPF15

Drug Labeling and Warnings

Drug Details

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MOISTURIZING SUNSCREEN SPF- zinc oxide and titanium oxide cream cream 
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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Moisturising Sunscreen SPF15

Bali Body Moisturising Sunscreen

Zinc Oxide

Titanium Dioxide

Keep out of reach of children.

A tanning and body oil.

Provides SPF15 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.

Aqua (purified water), Prunus Amygdalus Dulcis (Sweet Almond) oil, Coco-Caprylate/Caprate, Polyglycerl-3 Polyricnoleate, Aloe Barbadensis (Aloe Vera) leaf extract, Glycerin (Plant derived), Citrus Paradisi Peel (grapefruit) oil, Butyrospermum Parkii (Shea Butter), Cocos Nucifera Oil (Coconut), Rosa Canina (Rose Hip) fruit oil, Simmondsia Chinensis (Jojoba) oil, Tocopherol (Vitamin E), Gylceryl Caprylate, Isostearic Acid, Natural Coconut Fragrance*, Phenoxyethanol, Hexyl Cinnamal.

*naturally derived.

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.

MOISTURIZING SUNSCREEN SPF 
zinc oxide and titanium oxide cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70630-1604
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.6 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
JOJOBA OIL (UNII: 724GKU717M)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
WATER (UNII: 059QF0KO0R)  
ALMOND OIL (UNII: 66YXD4DKO9)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
SHEA BUTTER (UNII: K49155WL9Y)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70630-1604-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/20/2016
Labeler - Bali Body Pty Ltd (757840223)
Registrant - Bali Body Pty Ltd (757840223)

Revised: 8/2019
 
Bali Body Pty Ltd


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