SOLEO ORGANICS SUNSCREEN- zinc oxide cream

Soleo Organics Sunscreen by

Drug Labeling and Warnings

Soleo Organics Sunscreen by is a Otc medication manufactured, distributed, or labeled by SE Operations Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIRECTIONS

Squeeze and shake tube well before use. Apply liberally to all exposed skin 20 minutes before sun exposure and as needed. Reapply regularly and after swimming, heavy perspiration or towelling.

STORAGE AND HANDLING

Store below 30°C/86°F.

INDICATIONS

• helps prevent sunburn
• higher SPF gives more sunburn protection
• very water resistant

WARNINGS

• 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

SUN ALERT

Limiting sun exposure, wearing protective clothing and using sun screens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

ENQUIRIES

Skin Elements Limited
32 Ord St, West Perth, Western Australia, Australia 6005
T: (+61) 8 9486 4782, T: 1300 663 780
E: info@soleoorganics.com
www.soleoorganics.com

Full Ingredient

Vitis vinifera seed oil (grapeseed), Zinc oxide, Helianthus annuus seed oil (sunflower), Capric/caprylic triglyceride, Vegetable oil, Candelilla Cera, Cera alba (beeswax), Macadamia ternifolia seed oil, Theobroma grandiflorum seed butter, Camellia sinensis leaf extract (green tea), Anthemis nobilis flower extract (roman chamomile), Lecithin, Carthamus tintorius seed oil (safflower), Cucumis sativus fruit extract (cucumber), Tocopherol acetate (natural Vitamin E).

Active Ingredient

Zinc oxide 22.3%

PRINCIPAL DISPLAY PANEL - 80 g Tube Carton

I'M ORGANIC... SQUEEZE ME BEFORE YOU USE ME!

MULTI
AWARD WINNING
#1
SUNSCREEN

soléo®
organics

all natural
SUNSCREEN

se formula

NO chemical UV absorbers
NO titanium dioxide
NO synthetic preservatives

30+
SPF

Very
Water
Resistant
3HR

UV-A
UV-B

nature's trusted suncare

net wt e 80g/2.8oz AUST-L116246

INGREDIENTS AND APPEARANCE

SOLEO ORGANICS SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11045-0303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	223 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GRAPE SEED OIL (UNII: 930MLC8XGG)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
MACADAMIA OIL (UNII: 515610SU8C)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SAFFLOWER OIL (UNII: 65UEH262IS)
CUCUMBER (UNII: YY7C30VXJT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11045-0303-1	40 g in 1 TUBE; Type 0: Not a Combination Product	01/20/2007
2	NDC: 11045-0303-2	1 in 1 CARTON	01/20/2007
2		80 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11045-0303-3	1 in 1 CARTON	01/20/2007
3		150 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/20/2007

Labeler - SE Operations Pty Ltd (752826854)