PERFECTLY POSH THROWING SHADE SPF30 BROAD SPECTRUM FACIAL SUNSCREEN- zinc oxide, titanium dioxide cream

Perfectly Posh THROWING SHADE SPF30 Broad Spectrum Facial Sunscreen by

Drug Labeling and Warnings

Perfectly Posh THROWING SHADE SPF30 Broad Spectrum Facial Sunscreen by is a Otc medication manufactured, distributed, or labeled by Perfectly Posh, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 6%

Titanium Dioxide 4.6%

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. Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Children under 6 months of age: ask a 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 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

Water (Aqua), Carthamus Tinctorius (Safflower) Oleosomes, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Diheptyl Succinate, Glycerin, Cetearyl Alcohol, Hydroxypropyl Starch Phosphate, Methylcellulose, Phenylpropanol, Alumina, Stearic Acid, Propanediol, Polyhydroxystearic Acid, Caprylyl Glycol, Gluconolactone, Lavandula Hybrida Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Triethoxycaprylylsilane, Sodium Benzoate, Sodium Phytate, Rhizobian Gum, Sodium Chloride, Sodium Hyaluronate, Phenoxyethanol, Tocopherol, Chlorphenesin, Citric Acid.

Other Information

Protect this product from excessive heat and sun.

PRINCIPAL DISPLAY PANEL

Broad Spectrum

Facial Sunscreen

SPF 30

1.6 oz/45 g

INGREDIENTS AND APPEARANCE

PERFECTLY POSH THROWING SHADE SPF30 BROAD SPECTRUM FACIAL SUNSCREEN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71140-0332
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYLPROPANOL (UNII: 0F897O3O4M)
CHLORPHENESIN (UNII: I670DAL4SZ)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARIC ACID D7 (UNII: T3B081197X)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
PHYTATE SODIUM (UNII: 88496G1ERL)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
RHIZOBIAN GUM (UNII: 0XNZ14VU7K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71140-0332-3	45 g in 1 TUBE; Type 0: Not a Combination Product	02/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/15/2017

Labeler - Perfectly Posh, LLC (063537897)