Label: PERFECTLY POSH THROWING SHADE SPF30 BROAD SPECTRUM FACIAL SUNSCREEN- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71140-0212-7 - Packager: Perfectly Posh, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 11, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
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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.
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Inactive Ingredients
Water/Aqua, Organic Carthamus Tinctorius (Safflower) Oleosomes, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Diheptyl Succinate, Glycerin, Stearyl Alcohol, Methylcellulose, Phenylpropanol, Alumina, Stearic Acid, Cetyl Alcohol, 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PERFECTLY POSH THROWING SHADE SPF30 BROAD SPECTRUM FACIAL SUNSCREEN
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71140-0212 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 DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) ALUMINUM OXIDE (UNII: LMI26O6933) SHEA BUTTER (UNII: K49155WL9Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) PHENYLPROPANOL (UNII: 0F897O3O4M) CHLORPHENESIN (UNII: I670DAL4SZ) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL ALCOHOL (UNII: 936JST6JCN) LAVENDER OIL (UNII: ZBP1YXW0H8) HEXASODIUM PHYTATE (UNII: ZBX50UG81V) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM BENZOATE (UNII: OJ245FE5EU) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TOCOPHEROL (UNII: R0ZB2556P8) STEARIC ACID D7 (UNII: T3B081197X) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLUCONOLACTONE (UNII: WQ29KQ9POT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71140-0212-7 45 g in 1 TUBE; Type 0: Not a Combination Product 11/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2016 Labeler - Perfectly Posh, LLC (063537897)