SPF-30 SPORT MOISTURIZER- zinc oxide lotion

SPF-30 SPORT moisturizer by

Drug Labeling and Warnings

SPF-30 SPORT moisturizer by is a Otc medication manufactured, distributed, or labeled by Juice Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see other information), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

• When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Due to the nature of mineral formulations, separation may occur. Shake tube before use. Apply a smooth, even layer to face, neck and top of hands before sun exposure and as needed. Children under 6 months of age, ask a doctor.

Other Information

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures incluing:

Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Organic juices of aloe barbadensis (organic aloe juice)1, pyrus malus (organic apple juice)1, vitis vinifera (organic white grape juice)1, cocos nucifera (organic coconut oil)1, caprylic/capric triglycerides, sorbitan stearate, ricinus communis (castor seed oil), hydrogenated methyl abietate, polyglyceryl-10 laurate, magnesium sulfate, helianthus annuus (organic sunflower seed oil)1, simmondsia chinensis (organic jojoba seed oil)1, tocopherol (Vitamin E), magnesium ascorbyl phosphate (Vitamin C), citrus limonum (lemon extract), iron oxides, phenethyl alcohol, ethylhexylglycerin, citrus reticulata (mandarin) & citrus aurantium (petitgrain) pure essential oils.

1 certified organic ingredient

Questions?

www.juicebeauty.com

PRINCIPAL DISPLAY PANEL - 110 mL Tube Label

SPORT

juice
BEAUTY®
THE ORGANIC SOLUTION™

SPF 30 Sport
Moisturizer

MADE WITH
CERTIFIED
ORGANIC
INGREDIENTS

Water Resistant
(80 minutes)
Antioxidant Rich

3.75 fl oz e 110 mL

INGREDIENTS AND APPEARANCE

SPF-30 SPORT MOISTURIZER 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55165-0104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
apple juice (UNII: 9871T0PD5P)
aloe vera leaf (UNII: ZY81Z83H0X)
coconut oil (UNII: Q9L0O73W7L)
medium-chain triglycerides (UNII: C9H2L21V7U)
sorbitan monostearate (UNII: NVZ4I0H58X)
polyglyceryl-10 laurate (UNII: MPJ2Q8WI8G)
magnesium sulfate (UNII: DE08037SAB)
sunflower oil (UNII: 3W1JG795YI)
jojoba oil (UNII: 724GKU717M)
tocopherol (UNII: R0ZB2556P8)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ferric oxide red (UNII: 1K09F3G675)
phenylethyl alcohol (UNII: ML9LGA7468)
ethylhexylglycerin (UNII: 147D247K3P)
mandarin oil (UNII: NJO720F72R)
citrus aurantium leafy twig oil (UNII: 5K6H1IMT3D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55165-0104-1	110 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/03/2012

Labeler - Juice Beauty (263151582)