SDARA SKINCARE MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide cream

SDARA Skincare Mineral Sunscreen SPF-30 by

Drug Labeling and Warnings

SDARA Skincare Mineral Sunscreen SPF-30 by is a Otc medication manufactured, distributed, or labeled by Tekboard Innovations Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 6.00%

Zinc Oxide 6.00%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection
• If used as directed with other sun protection measure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only not intended for ingestion.

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 of irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask doctor.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• 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 broad spectrum SPF 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.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia SInensis (Green Tea) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Lecithin, Octyl Palmitate, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum, Sodium Laurylglucosides, Hydroxypropylsulfonate.

Other Information:

• Protect the product in this container from excessive heat and direct sun.
• High sun protection product.

Package Labeling:

INGREDIENTS AND APPEARANCE

SDARA SKINCARE MINERAL SUNSCREEN SPF-30 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73627-058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALMOND OIL (UNII: 66YXD4DKO9)
SESAME OIL (UNII: QX10HYY4QV)
COCOA (UNII: D9108TZ9KG)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73627-058-03	1 in 1 BOX	01/15/2020
1		90 mL 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	01/15/2020

Labeler - Tekboard Innovations Inc (204060003)