Label: LAURA MERCIER PURE CANVAS PRIMER PROTECTING BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate, octocrylene, avobenzone, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-823-60 - Packager: Laura Mercier Cosmetics
- 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 December 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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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: Ask a doctor
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For sunscreen use:
- Inactive ingredients
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
LAURA MERCIER PURE CANVAS PRIMER PROTECTING BROAD SPECTRUM SPF 30 SUNSCREEN
octinoxate, octocrylene, avobenzone, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-823 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.681 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.515 g in 50 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.515 g in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1.010 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) XANTHAN GUM (UNII: TTV12P4NEE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ASCORBYL PALMITATE (UNII: QN83US2B0N) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ASCORBIC ACID (UNII: PQ6CK8PD0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) D&C RED NO. 6 (UNII: 481744AI4O) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-823-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/30/2021 Labeler - Laura Mercier Cosmetics (193691821)
