SOLAR GOO- zinc oxide, calendula officinalis salve

Solar Goo by

Drug Labeling and Warnings

Solar Goo by is a Homeopathic medication manufactured, distributed, or labeled by Sierra Sage Herbs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose Section

Sunscreen

Skin Protectant

Active Ingredients

Zinc Oxide (Non-Nano) 16%
Organic Calendula Officinalis (Calendula) Flowers 1X (HPUS)

Indications & Usage

-helps to prevent sunburn if used as directed with other sun
protection measures (see Directions) decrease the risk of skin cancer
and early skin aging caused by the sun.

Keep out of reach of children section

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

Warnings Section

Warnings For external use only.
When using this product avoid contact with eyes.

If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash occurs

Do not use on damaged or broken skin.

Storage

Store at room temperature.

Dosage & Administration Section

Apply liberally 15 minutes before sun exposure
reapply:
after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
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 suncream with a broad spectrum SPF of 15 or higher
and other sun protection measures including:
limit time in the sun, especially from 10am -2pm
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive Ingredients

Beeswax (cera alba), Organic Cocos nucifera (Coconut) Oil, Organic Helianthus annus (Sunflower) Oil, Non-GMO (100% Sunflower) Mixed Tocopherols (Vitamin E), Butyrospermum parkii (Shea Butter).

Principal Display Panel

INGREDIENTS AND APPEARANCE

SOLAR GOO 
zinc oxide, calendula officinalis salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70994-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18 g  in 113.4 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 113.4 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70994-106-11	1 in 1 BOX	04/01/2016
1	NDC: 70994-106-04	17 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70994-106-09	1 in 1 BOX	04/01/2016
2	NDC: 70994-106-01	19.8 g in 1 CAN; Type 0: Not a Combination Product
3	NDC: 70994-106-10	1 in 1 BOX	04/01/2016
3	NDC: 70994-106-02	51.7 g in 1 CAN; Type 0: Not a Combination Product
4	NDC: 70994-106-03	113.4 g in 1 CAN; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2016

Labeler - Sierra Sage Herbs LLC (006970452)