Label: UV ESSENTIEL COMPLETE UV PROTECTION SUNSCREEN ANTIOXIDANT ANTI-POLLUTION BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, and octocrylene emulsion
- NDC Code(s): 68745-2157-1
- Packager: CHANEL PARFUMS BEAUTE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 8, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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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
- Children under 6 months of age: Ask a doctor
- For sunscreen use:
- Other information
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Inactive ingredients
water • glycerin • coco-caprylate/caprate caprylyl • triacontanyl PVP • alcohol • pentylene glycol • moringa oil/hydrogenated moringa oil esters • jojoba esters • behenyl alcohol • squalane • potassium cetyl phosphate • yeast extract • gardenia tahitensis flower extract • zingiber officinale (ginger) root extract • glycyrrhiza glabra (licorice) root extract • polyglycerin-3 • dipropylene glycol • C14-22 alcohols • pullulan • dimethicone • camellia oleifera seed oil • phytosteryl canola glycerides • fragrance • butyrospermum parkii (shea) butter extract • sorbitol • chlorphenesin • caprylyl glycol • C12-20 alkyl glucoside • xanthan gum • sodium hyaluronate • acacia decurrens flower wax • helianthus annuus (sunflower) seed wax • butylene glycol • acacia senegal gum • phytic acid • trehalose • 1,2-hexanediol • sodium hydroxide • tocopherol • glucose • sodium citrate • ascorbyl palmitate • sodium benzoate • citric acid
BU000009A - Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
UV ESSENTIEL COMPLETE UV PROTECTION SUNSCREEN ANTIOXIDANT ANTI-POLLUTION BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, and octocrylene emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2157 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) glycerin (UNII: PDC6A3C0OX) cocoyl caprylocaprate (UNII: 8D9H4QU99H) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) alcohol (UNII: 3K9958V90M) pentylene glycol (UNII: 50C1307PZG) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) docosanol (UNII: 9G1OE216XY) squalane (UNII: GW89575KF9) potassium cetyl phosphate (UNII: 03KCY6P7UT) yeast, unspecified (UNII: 3NY3SM6B8U) GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y) ginger (UNII: C5529G5JPQ) glycyrrhiza glabra (UNII: 2788Z9758H) polyglycerin-3 (UNII: 4A0NCJ6RD6) dipropylene glycol (UNII: E107L85C40) C14-22 alcohols (UNII: B1K89384RJ) pullulan (UNII: 8ZQ0AYU1TT) dimethicone (UNII: 92RU3N3Y1O) camellia oil (UNII: T1PE06G0VE) shea butter (UNII: K49155WL9Y) sorbitol (UNII: 506T60A25R) chlorphenesin (UNII: I670DAL4SZ) caprylyl glycol (UNII: 00YIU5438U) C12-20 alkyl glucoside (UNII: K67N5Z1RUA) xanthan gum (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) acacia decurrens flower wax (UNII: AU6XZE9IY9) helianthus annuus seed wax (UNII: 42DG15CHXV) butylene glycol (UNII: 3XUS85K0RA) acacia (UNII: 5C5403N26O) fytic acid (UNII: 7IGF0S7R8I) trehalose (UNII: B8WCK70T7I) 1,2-hexanediol (UNII: TR046Y3K1G) sodium hydroxide (UNII: 55X04QC32I) tocopherol (UNII: R0ZB2556P8) anhydrous dextrose (UNII: 5SL0G7R0OK) sodium citrate, unspecified form (UNII: 1Q73Q2JULR) ascorbyl palmitate (UNII: QN83US2B0N) sodium benzoate (UNII: OJ245FE5EU) anhydrous citric acid (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2157-1 1 in 1 CARTON 05/01/2023 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 05/01/2023 Labeler - CHANEL PARFUMS BEAUTE (275137669) Establishment Name Address ID/FEI Business Operations CHANEL PARFUMS BEAUTE 277032517 MANUFACTURE(68745-2157) , LABEL(68745-2157)
