WATERMELON TANNING OIL SPF6- octocrylene, octinoxate, avobenzone oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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

Therapeutic indications:

Helps prevent sunburn.

Authorization status:

OTC monograph not final

Summary of Product characteristics

WATERMELON TANNING OIL SPF6- OCTOCRYLENE, OCTINOXATE, AVOBENZONE 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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WATERMELON TANNING 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 and 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.
ACTIVE INGREDIENTS:
Octocrylene 2.5%,
Octinoxate 2.5%,
Avobenzone 1%.
PURPOSE:
Sunsreen
INACTIVE INGREDIENTS:
Vitis Vinifera (Grape) Seed Oil, Prunus Amygdalus Dulcis (Sweet
Almond) Oil, Cocos
Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Hydrogenated Soy
Polyglycerides, Citrullus
Vulgaris (Watermelon) Seed Oil, Octocrylene, Ethylhexyl
Methoxycinnamate, Butyl
Methoxydibenzoylmethane, Glycine Soja (Soybean) Oil, Tocopherol,
Natural Watermelon
Fragrance (Naturally Dervied), C15-23, BHT.
PACKAGE LABELING:
WATERMELON TANNING OIL SPF6
octocrylene, octinoxate, avobenzone oil
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70630-0005
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
OCTOCRYLENE
25 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
25 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOB