SPF 30 OIL-FREE MOISTURIZER- zinc oxide lotion

SPF 30 Oil-Free Moisturizer by

Drug Labeling and Warnings

SPF 30 Oil-Free 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 Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings

For external use only

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Due to the nature of mineral formulations shake and knead the tube before use. Moisturize daily by applying generously and evenly 15 minutes before sun exposure. May be used over moisturizer or alone.
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  - limit time in the sun, especially from 10 a.m.–2 p.m.
  - wear long-sleeved shirts, pants, hats, and sunglasses
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor.
  Après avoir nettoyé le visage le matin, appliquer sur peau humide.
Inactive Ingredients

Aloe barbadensis leaf juice1, caprylic/capric triglyceride2, pentylene glycol2, polyglyceryl-6 distearate2, glyceryl stearate2, sorbitan sesquioleate2, pyrus malus (apple) juice1, vitis vinifera (grape) juice2, ascorbyl glucoside (Vitamin C), hyaluronic acid, bisabolol2, punica granatum (pomegranate) pericarp extract2, punica granatum (pomegranate) extract2, laminaria digitata (sea kelp) extract1, pongamia pinnata seed extract2, cucumis sativus (cucumber) fruit extract1, citrus limon (lemon) fruit extract2, glycerin2, xanthan gum, polyhydroxystearic acid2, sodium stearoyl glutamate, polyglyceryl-6 polyricinoleate2, maltodextrin2, citric acid, silica, iron oxides (CI 77491, CI 77492, CI 77499), jojoba esters2, simmondsia chinensis (jojoba) seed oil2.

1 certified organic ingredient

2 plant-derived

Other Information

Protect the product in this container from excessive heat and direct sun

Questions?

www.juicebeauty.com

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

jUiCE BEAUTY
THE ORGANIC SOLUTION™

SPF 30 Oil-Free**
Moisturizer

broad spectrum
SPF 30 sunscreen

60 mL / 2 fl oz
NPN 80040587

Principal Display Panel - 60 mL Tube Carton

INGREDIENTS AND APPEARANCE

SPF 30 OIL-FREE MOISTURIZER
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55165-0202
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
pentylene glycol (UNII: 50C1307PZG)
polyglyceryl-6 distearate (UNII: Z35I17EQOP)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
sorbitan sesquioleate (UNII: 0W8RRI5W5A)
WINE GRAPE JUICE (UNII: JHQ6158A7R)
apple juice (UNII: 9871T0PD5P)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
hyaluronic acid (UNII: S270N0TRQY)
LEVOMENOL (UNII: 24WE03BX2T)
POMEGRANATE FRUIT RIND (UNII: RS999V57DU)
POMEGRANATE (UNII: 56687D1Z4D)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
CUCUMBER (UNII: YY7C30VXJT)
LEMON (UNII: 24RS0A988O)
glycerin (UNII: PDC6A3C0OX)
xanthan gum (UNII: TTV12P4NEE)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
sodium stearoyl glutamate (UNII: 65A9F4P024)
polyglyceryl-6 polyricinoleate (UNII: YPM0ZOC2HR)
maltodextrin (UNII: 7CVR7L4A2D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
JOJOBA OIL (UNII: 724GKU717M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55165-0202-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	05/15/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	05/15/2010

Labeler - Juice Beauty (263151582)