Label: SEA STARWORT SOOTHING SUNSCREEN SPF 35- titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 75391-002-30 - Packager: CU LIFESTYLE LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 22, 2020
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PRINCIPAL DISPLAY PANEL
Sea Starwort Soothing Sunscreen SPF 35
30 ml 1.0 fl. oz.
Drug Facts
Active Ingredients
Titanium Dioxide 9.7 %
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
●Stop use and ask a doctor if rash occurs
●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
● Apply to all skin exposed to the sun
● Reapply at least every 2 hours
● Use a water-resistant sunscreen if swimming or sweating
● Children under 6 months of age: 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 10 a.m. - 2 p.m.
● Wear long-sleeved shirts, pants, hats, and sunglasses
Ingredients
Aqua, Pyrus malus (apple) fruit water*, Titanium Dioxide, Caprylic /Capric Triglyceride, C10-18 Triglycerides, Glycerin, Dicaprylyl Ether, Simmondsia Chinensis (Jojoba) Seed Oil*, Silica, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Jojoba esters, Magnesium Sulfate, Sodium Chloride, Glyceryl Caprylate, Polyhydroxystearic Acid, Glyceryl Undecylenate, Xanthan Gum, Tocopherol, Bisabolol, Aster Maritima/Tripolium Extract, Chamomilla Recutita (Matricaria) Flower Extract*
*Ingredients from organic farming.
Other Information
● Protect the product in this container from excessive heat and direct sun
SHELF LIFE | 2 years
INNA ORGANIC CO., LTD.
12F., No. 178, Sec, 2, Nanjing E. Rd., Zhongshan Dist., Taipei City 104, Taiwan (R.O.C)
+886 -2 – 7746 - 7089
en.innaorganic.com
Made in Taiwan | Product liability insurance included.
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INGREDIENTS AND APPEARANCE
SEA STARWORT SOOTHING SUNSCREEN SPF 35
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75391-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.91 mg in 30 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) WATER (UNII: 059QF0KO0R) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DICAPRYLYL ETHER (UNII: 77JZM5516Z) XANTHAN GUM (UNII: TTV12P4NEE) APPLE FRUIT OIL (UNII: 9NT987I3A8) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75391-002-30 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/15/2020 Labeler - CU LIFESTYLE LLC (010080461)