DAILY MINERAL SUNSCREEN- zinc oxide cream

Daily Mineral Sunscreen by

Drug Labeling and Warnings

Daily Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Dermstore.com, Fallien Cosmeceuticals, LTD., Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 16%

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.

• 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
• use a water resistant product if swimming or sweating
• reapply at least every 2 hours
• Children under 6 months: Ask a doctor
• 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 10am-2pm. Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer

Other Information

• protect this product from excessive heat and direct sun
• may stain some fabrics

Principal Display Panel – 1.75 oz Carton Label

DAILY
MINERAL
SUNSCREEN

SHEER TINT

BROAD SPECTRUM
SPF 40

DERMSTORE

NET WT. 1.75 oz / 50 g

INGREDIENTS AND APPEARANCE

DAILY MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12569-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE NP (UNII: 4370DF050B)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone 20 (UNII: H8YMB5QY0D)
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Dimethiconol (2000 CST) (UNII: T74O12AN6Y)
Brown Iron Oxide (UNII: 1N032N7MFO)
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12569-020-85	1 in 1 CARTON	09/01/2020
1		50 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 12569-020-86	1 in 1 CARTON	09/01/2020
2		22 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	09/01/2020

Labeler - Dermstore.com (015792160)

Registrant - Fallien Cosmeceuticals, LTD. (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS(12569-020)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(12569-020) , PACK(12569-020)