Label: COMPLEXION PROTECTION MOISTURIZING SUNSCREEN- titanium dioxide cream
- NDC Code(s): 71987-001-00
- Packager: Hale Comeceuticals
- 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 December 14, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- For external use only
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Inactive Ingredients
Alumina, Borago Officinalis Seed Oil, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteareth-20, Catearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Glycerin, Glyceryl Stearate, Hydrogenated Vegetable Oil, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Squalane, Sodium Hyaluronate, Sorbic Acid, Stearic Acid, Tocopheryl Acetate, Urea, Water, Xanthan Gum.
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Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- reapply :
- after 40 minutes of swimming or sweating
- immediately after towel drying
- 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 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglass
- children under 6 months: Ask a doctor.
- Other Information
- Questions or comments?
- Package Labeling
-
INGREDIENTS AND APPEARANCE
COMPLEXION PROTECTION MOISTURIZING SUNSCREEN
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71987-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) BORAGE SEED OIL (UNII: F8XAG1755S) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) OLIVE OIL (UNII: 6UYK2W1W1E) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) SQUALANE (UNII: GW89575KF9) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SORBIC ACID (UNII: X045WJ989B) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71987-001-00 74 mL in 1 TUBE; Type 0: Not a Combination Product 01/09/2018 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/09/2018 12/31/2024 Labeler - Hale Comeceuticals (168405822)
